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FDA 510(k)

COACUTE HEPARIN

K-Number: K952514 · 1995-11-20

ApplicantChromogenix AB
Decision Date1995-11-20
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

COACUTE HEPARIN is the device name listed in this FDA 510(k) record. The listed applicant is Chromogenix AB. It received FDA 510(k) clearance on 1995-11-20 under 510(k) number K952514. 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 COACUTE HEPARIN?

COACUTE HEPARIN is a medical device that received FDA 510(k) clearance on 1995-11-20. The listed applicant is Chromogenix AB. The 510(k) number is K952514.

When did COACUTE HEPARIN receive FDA 510(k) clearance?

COACUTE HEPARIN received FDA 510(k) clearance on 1995-11-20, under 510(k) number K952514.

Who is the listed applicant for COACUTE HEPARIN?

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 COACUTE HEPARIN?

The FDA product code for COACUTE HEPARIN is KFF.

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 ASSAYK922201COAMATE PROTEIN C 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

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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