510(k) Premarket Notification | 合法醫療器材資訊網
DeviceClassificationName,c-reactiveprotein,antigen,antiserum,andcontrol22.510(k)Number,K010236.DeviceName,IMMAGEIMMUNOCHEMISTRYSYSTEMHIGHSENSITIVITYC-REACTIVEPROTEIN(CRPH)REAGENT.Applicant.BECKMANCOULTER,INC.200SOUTHKRAEMERBL
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
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References Learn more... (www.fda.gov)
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510(k) Premarket Notification | 合法醫療器材資訊網
2001年4月5日 — Device Classification Name, c-reactive protein, antigen, antiserum, and control22. 510(k) Number, K010236. Device Name, IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT. Applicant. BECKMAN COULTER, INC. 200 SOU Read More
510(k) Premarket Notification | 合法醫療器材資訊網
Device Classification Name, c-reactive protein, antigen, antiserum, and control22. 510(k) Number, K010236. Device Name, IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT. Applicant. BECKMAN COULTER, INC. 200 SOUTH KRAEMER BL Read More
Beckman Coulter 474630 | 合法醫療器材資訊網
Reagent Cardiac / Immunoassay High-Sensitivity C-Reactive Protein (hsCRP) For IMMAGE 800 System 300 Tests · REAGENT, CRPH IMMAGE D/S · No Image. Read More
CRPH Chemistry Information Sheet High Sensitivity C ... | 合法醫療器材資訊網
2010年9月12日 — High Sensitivity CRPH reagent, when used in conjunction with ... Blood levels of C-Reactive Protein (CRP) are known to rise rapidly from ... Read More
CRPH Chemistry Information Sheet High Sensitivity Cardiac C ... | 合法醫療器材資訊網
2020年3月16日 — 2020 Beckman Coulter, Inc. All rights reserved. ... High Sensitivity Cardiac C-Reactive Protein (CRPH) reagent, when used in conjunction with ... Blood levels of C-Reactive Protein (CRP) are known to rise rapidly from normal ... Read More
Immage Immunochemistry System High Sensitivity C | 合法醫療器材資訊網
FDA premarket device registration for Immage Immunochemistry System High Sensitivity C-reactive Protein (crph) Reagent distributed by BECKMAN COULTER, ... Read More
IMMAGE Immunochemistry Systems CCRP Chemistry ... | 合法醫療器材資訊網
2010年8月13日 — High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800. Immunochemistry Systems and ... Read More
IMMAGE® Immunochemistry Systems Chemistry Information ... | 合法醫療器材資訊網
High Sensitivity Cardiac C-Reactive Protein (CCRP) reagent, when used in conjunction with IMMAGE® 800 Immunochemistry Systems and Calibrator 5 Plus, ... Read More
K010236 IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH ... | 合法醫療器材資訊網
IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PROTEIN (CRPH) REAGENT,BECKMAN COULTER, INC.,Product Code: DCK. Read More
KY71o0C 2 | 合法醫療器材資訊網
High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent. 1.0. Submitted By: ... CCRP Reagent. IMMAGE Immunochemistry Beckman ... Beckman. K926236/A. Coulter, Inc. *Dade Behring Inc. (Newark, DE). 5.0. Description: ... IMMAGE® System High Sensitivity Ca Read More
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