FDA 510(k)

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511

K-Number: K050713 · 2005-06-06

Decision Date2005-06-06

Product CodeDCN

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 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 2005-06-06 under 510(k) number K050713. 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 DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511?

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 is a medical device that received FDA 510(k) clearance on 2005-06-06. The listed applicant is Good Biotech Corp.. The 510(k) number is K050713.

When did DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 receive FDA 510(k) clearance?

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 received FDA 510(k) clearance on 2005-06-06, under 510(k) number K050713.

Who is the listed applicant for DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511?

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 DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511?

The FDA product code for DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 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,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 K021882CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

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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

View on FDA Database →

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