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FDA 510(k)

HEPARINOMETER

K-Number: K834024 · 1984-06-11

ApplicantWestern Laboratories Corp.
Decision Date1984-06-11
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPARINOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Western Laboratories Corp.. It received FDA 510(k) clearance on 1984-06-11 under 510(k) number K834024. 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 HEPARINOMETER?

HEPARINOMETER is a medical device that received FDA 510(k) clearance on 1984-06-11. The listed applicant is Western Laboratories Corp.. The 510(k) number is K834024.

When did HEPARINOMETER receive FDA 510(k) clearance?

HEPARINOMETER received FDA 510(k) clearance on 1984-06-11, under 510(k) number K834024.

Who is the listed applicant for HEPARINOMETER?

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

What is the FDA product code for HEPARINOMETER?

The FDA product code for HEPARINOMETER is KFF.

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Other records listing Western Laboratories Corp. 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.

K830468MODEL 200K821834MODEL 100 BICARBONATE CONDUCTIVITYK821415MODEL 90 BCK821414MODEL 80 BCK801303MODEL 90 PRESSURE/CONDUCTIVITY/TEMP TESTK780932MODEL 80 CONDUCTIVITY/TEMP.TEST UNIT

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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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