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FDA 510(k)

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50

K-Number: K023990 · 2003-03-19

ApplicantPrecision Biologic
Decision Date2003-03-19
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 is the device name listed in this FDA 510(k) record. The listed applicant is Precision Biologic. It received FDA 510(k) clearance on 2003-03-19 under 510(k) number K023990. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50?

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 is a medical device that received FDA 510(k) clearance on 2003-03-19. The listed applicant is Precision Biologic. The 510(k) number is K023990.

When did CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 receive FDA 510(k) clearance?

CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 received FDA 510(k) clearance on 2003-03-19, under 510(k) number K023990.

Who is the listed applicant for CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50?

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

What is the FDA product code for CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50?

The FDA product code for CHROMOCHECK PROTEIN C 25; CHROMOCHECK PROTEIN C 50 is GGP.

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Other records listing Precision Biologic as applicant

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K193556Cryocheck Hex LAK193204Cryocheck Chromogenic Factor VIIIK032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLK023991CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10K990580CRYOCHECK LA SURE, MODEL SUR25-10

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Related Devices (Code: GGP)

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.

K251440CRYOcheck Chromogenic Factor VIIIPrecision Biologic, Inc.K230852HemosIL Chromogenic Factor IXInstrumentation Laboratory CompanyK220728vWF AgSiemens Healthcare Diagnostics Products GmbHK214002CRYOcheck Chromogenic Factor IXPrecision Biologic, Inc.K223402HemosIL von Willebrand Factor AntigenInstrumentation Laboratory COK200033HemosIL von Willebrand Factor AntigenInstrumentation Laboratory CO

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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