FDA 510(k)

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010

K-Number: K020603 · 2002-06-13

Decision Date2002-06-13

Product CodeDCN

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 is the device name listed in this FDA 510(k) record. The listed applicant is Good Biotech Corp.. It received FDA 510(k) clearance on 2002-06-13 under 510(k) number K020603. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010?

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 is a medical device that received FDA 510(k) clearance on 2002-06-13. The listed applicant is Good Biotech Corp.. The 510(k) number is K020603.

When did CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 receive FDA 510(k) clearance?

CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 received FDA 510(k) clearance on 2002-06-13, under 510(k) number K020603.

Who is the listed applicant for CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010?

The FDA 510(k) record lists Good Biotech Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010?

The FDA product code for CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 is DCN.

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Other records listing Good Biotech Corp. as applicant

K063766TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C K052617FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; FERRITIN CONTROLS, LEVEL-L & LEVEL-H,K050713DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 K050576MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H K022725CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 K021757CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

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Related Devices (Code: DCN)

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbH K221119RCRP Flex reagent cartridgeSiemens Healthcare Diagnostics, Inc.K192072Tina-quant C-Reactive Protein IVRoche Diagnostics Operations (Rdo)K180099Optilite High Sensitivity C-Reactive Protein KitThe Binding Site Group , Ltd.K172868Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein ControlsThe Binding Site Group , Ltd.K171498MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentMeso Scale Diagnostics, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.