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FDA 510(k)

DIACROM * HEPARIN

K-Number: K832373 · 1983-09-29

ApplicantWellcome Diagnostics
Decision Date1983-09-29
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DIACROM * HEPARIN is the device name listed in this FDA 510(k) record. The listed applicant is Wellcome Diagnostics. It received FDA 510(k) clearance on 1983-09-29 under 510(k) number K832373. 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 DIACROM * HEPARIN?

DIACROM * HEPARIN is a medical device that received FDA 510(k) clearance on 1983-09-29. The listed applicant is Wellcome Diagnostics. The 510(k) number is K832373.

When did DIACROM * HEPARIN receive FDA 510(k) clearance?

DIACROM * HEPARIN received FDA 510(k) clearance on 1983-09-29, under 510(k) number K832373.

Who is the listed applicant for DIACROM * HEPARIN?

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

What is the FDA product code for DIACROM * HEPARIN?

The FDA product code for DIACROM * HEPARIN is KFF.

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Other records listing Wellcome Diagnostics 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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