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FDA 510(k)

CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510

K-Number: K021882 · 2002-07-11

ApplicantGood Biotech Corp.
Decision Date2002-07-11
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 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 2002-07-11 under 510(k) number K021882. 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 CRP CALIBRATOR SET, CATALOG NO: 1510?

CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 is a medical device that received FDA 510(k) clearance on 2002-07-11. The listed applicant is Good Biotech Corp.. The 510(k) number is K021882.

When did CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 receive FDA 510(k) clearance?

CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 received FDA 510(k) clearance on 2002-07-11, under 510(k) number K021882.

Who is the listed applicant for CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510?

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 CRP CALIBRATOR SET, CATALOG NO: 1510?

The FDA product code for CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 is DCN.

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Other records listing Good Biotech Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K063766TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,CK052617FERRITIN 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: 4511K050576MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-HK022725CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013K021757CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET

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Related Devices (Code: DCN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232624CardioPhase® hsCRPSiemens Healthcare Diagnostic Products GmbHK221119RCRP 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.

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