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FDA 510(k)

HEMOLAB HEPARICHROM ASSAY

K-Number: K934274 · 1994-05-06

ApplicantBiomerieux Vitek, Inc.
Decision Date1994-05-06
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEMOLAB HEPARICHROM ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1994-05-06 under 510(k) number K934274. 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 HEMOLAB HEPARICHROM ASSAY?

HEMOLAB HEPARICHROM ASSAY is a medical device that received FDA 510(k) clearance on 1994-05-06. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K934274.

When did HEMOLAB HEPARICHROM ASSAY receive FDA 510(k) clearance?

HEMOLAB HEPARICHROM ASSAY received FDA 510(k) clearance on 1994-05-06, under 510(k) number K934274.

Who is the listed applicant for HEMOLAB HEPARICHROM ASSAY?

The FDA 510(k) record lists Biomerieux Vitek, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEMOLAB HEPARICHROM ASSAY?

The FDA product code for HEMOLAB HEPARICHROM ASSAY is KFF.

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Other records listing Biomerieux Vitek, Inc. as applicant

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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

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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