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FDA 510(k)

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY

K-Number: K853239 · 1985-11-05

ApplicantHaemachem, Inc.
Decision Date1985-11-05
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Haemachem, Inc.. It received FDA 510(k) clearance on 1985-11-05 under 510(k) number K853239. 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 HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY?

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY is a medical device that received FDA 510(k) clearance on 1985-11-05. The listed applicant is Haemachem, Inc.. The 510(k) number is K853239.

When did HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY receive FDA 510(k) clearance?

HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY received FDA 510(k) clearance on 1985-11-05, under 510(k) number K853239.

Who is the listed applicant for HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY?

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

What is the FDA product code for HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY?

The FDA product code for HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY is KFF.

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Other records listing Haemachem, Inc. 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.

K903874FIBRINOTEST(TM) - FIBRINOGEN ASSAYK841957BOVINE FACTOR XA-HUMAN FACTOR XAK841956BOVINE THROMBIN, HUMAN THROMBIN

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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