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FDA 510(k)

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY

K-Number: K902393 · 1990-09-25

ApplicantKabi Diagnostica
Decision Date1990-09-25
Product CodeJBQ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Kabi Diagnostica. It received FDA 510(k) clearance on 1990-09-25 under 510(k) number K902393. The device is classified under product code JBQ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COACUTE ANTITHROMBIN CHROMOGENIC ASSAY?

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1990-09-25. The listed applicant is Kabi Diagnostica. The 510(k) number is K902393.

When did COACUTE ANTITHROMBIN CHROMOGENIC ASSAY receive FDA 510(k) clearance?

COACUTE ANTITHROMBIN CHROMOGENIC ASSAY received FDA 510(k) clearance on 1990-09-25, under 510(k) number K902393.

Who is the listed applicant for COACUTE ANTITHROMBIN CHROMOGENIC ASSAY?

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

What is the FDA product code for COACUTE ANTITHROMBIN CHROMOGENIC ASSAY?

The FDA product code for COACUTE ANTITHROMBIN CHROMOGENIC ASSAY is JBQ.

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 Kabi Diagnostica 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.

K901874COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY

Related Devices (Code: JBQ)

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.

K242952INNOVANCE AntithrombinSiemens Healthcare Diagnostic Products GmbHK081769INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5Siemens Healthcare DiagnosticsK070301HEMOSIL ANTITHROMBINInstrumentation Laboratory COK062431HEMOSIL LIQUID ANTITHROMBINInstrumentation Laboratory COK043007BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105Hyphen BiomedK033775HEMOSIL LIQUID ANTITHROMBIN XLInstrumentation 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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