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FDA 510(k)

IL TEST 97575-15, HEPARIN ASSAY

K-Number: K864211 · 1987-01-05

ApplicantInstrumentation Laboratory CO
Decision Date1987-01-05
Product CodeKFF
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IL TEST 97575-15, HEPARIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1987-01-05 under 510(k) number K864211. 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 IL TEST 97575-15, HEPARIN ASSAY?

IL TEST 97575-15, HEPARIN ASSAY is a medical device that received FDA 510(k) clearance on 1987-01-05. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K864211.

When did IL TEST 97575-15, HEPARIN ASSAY receive FDA 510(k) clearance?

IL TEST 97575-15, HEPARIN ASSAY received FDA 510(k) clearance on 1987-01-05, under 510(k) number K864211.

Who is the listed applicant for IL TEST 97575-15, HEPARIN ASSAY?

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

What is the FDA product code for IL TEST 97575-15, HEPARIN ASSAY?

The FDA product code for IL TEST 97575-15, HEPARIN ASSAY is KFF.

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Other records listing Instrumentation Laboratory 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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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