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FDA 510(k)

HBPM/LMWH CONTROL KIT

K-Number: K943519 · 1995-09-26

ApplicantAmerican Bioproducts Co.
Decision Date1995-09-26
Product CodeKFF
Advisory CommitteeHE
DecisionUnknown

Device Summary

HBPM/LMWH CONTROL KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1995-09-26 under 510(k) number K943519. The device is classified under product code KFF. It was reviewed by the HE advisory panel. FDA Decision: Unknown.

Frequently Asked Questions

What is the HBPM/LMWH CONTROL KIT?

HBPM/LMWH CONTROL KIT is a medical device that received FDA 510(k) clearance on 1995-09-26. The listed applicant is American Bioproducts Co.. The 510(k) number is K943519.

When did HBPM/LMWH CONTROL KIT receive FDA 510(k) clearance?

HBPM/LMWH CONTROL KIT received FDA 510(k) clearance on 1995-09-26, under 510(k) number K943519.

Who is the listed applicant for HBPM/LMWH CONTROL KIT?

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

What is the FDA product code for HBPM/LMWH CONTROL KIT?

The FDA product code for HBPM/LMWH CONTROL KIT is KFF.

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Other records listing American Bioproducts Co. 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.

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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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