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FDA 510(k)

COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY

K-Number: K901874 · 1990-07-20

ApplicantKabi Diagnostica
Decision Date1990-07-20
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COATEST LMW HEPARIN/HEPARIN 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 1990-07-20 under 510(k) number K901874. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY?

COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY is a medical device that received FDA 510(k) clearance on 1990-07-20. The listed applicant is Kabi Diagnostica. The 510(k) number is K901874.

When did COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY receive FDA 510(k) clearance?

COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY received FDA 510(k) clearance on 1990-07-20, under 510(k) number K901874.

Who is the listed applicant for COATEST LMW HEPARIN/HEPARIN 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 COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY?

The FDA product code for COATEST LMW HEPARIN/HEPARIN CHROMOGENIC ASSAY is KFF.

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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.

K902393COACUTE ANTITHROMBIN CHROMOGENIC ASSAY

Related Devices (Code: KFF)

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.

K260214STA® - Liquid Anti-XaDiagnostica Stago, Inc.K213464HemosIL Liquid Anti-XaInstrumentation Laboratory COK162540INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW ControlsSiemens Healthcare Diagnostics Prodcts GmbHK111822STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWHDiagnostica Stago, Inc.K090209HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLSInstrumentation Laboratory COK050367BIOPHEN HEPARIN 3, BIOPHEN HEPARIN 6Hyphen Biomed

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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