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FDA 510(k)

COAMATE PROTEIN C CHROMOGENIC ASSAY

K-Number: K922201 · 1992-12-07

ApplicantChromogenix AB
Decision Date1992-12-07
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COAMATE PROTEIN C CHROMOGENIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenix AB. It received FDA 510(k) clearance on 1992-12-07 under 510(k) number K922201. 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 COAMATE PROTEIN C CHROMOGENIC ASSAY?

COAMATE PROTEIN C CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1992-12-07. The listed applicant is Chromogenix AB. The 510(k) number is K922201.

When did COAMATE PROTEIN C CHROMOGENIC ASSAY receive FDA 510(k) clearance?

COAMATE PROTEIN C CHROMOGENIC ASSAY received FDA 510(k) clearance on 1992-12-07, under 510(k) number K922201.

Who is the listed applicant for COAMATE PROTEIN C CHROMOGENIC ASSAY?

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

What is the FDA product code for COAMATE PROTEIN C CHROMOGENIC ASSAY?

The FDA product code for COAMATE PROTEIN C CHROMOGENIC ASSAY is GGP.

Related Clinical Trials

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.

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Other records listing Chromogenix AB 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.

K963111COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V SK952515COACUTE ANTITHROMBIN R CHROMOGENIC ASSAYK952514COACUTE HEPARIN

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

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

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