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FDA 510(k)

IL SYSTEM 810, ACL AND THE REAGENT SETS

K-Number: K862301 · 1986-09-03

ApplicantInstrumentation Laboratory CO
Decision Date1986-09-03
Product CodeGJA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IL SYSTEM 810, ACL AND THE REAGENT SETS 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 1986-09-03 under 510(k) number K862301. The device is classified under product code GJA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL SYSTEM 810, ACL AND THE REAGENT SETS?

IL SYSTEM 810, ACL AND THE REAGENT SETS is a medical device that received FDA 510(k) clearance on 1986-09-03. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K862301.

When did IL SYSTEM 810, ACL AND THE REAGENT SETS receive FDA 510(k) clearance?

IL SYSTEM 810, ACL AND THE REAGENT SETS received FDA 510(k) clearance on 1986-09-03, under 510(k) number K862301.

Who is the listed applicant for IL SYSTEM 810, ACL AND THE REAGENT SETS?

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 SYSTEM 810, ACL AND THE REAGENT SETS?

The FDA product code for IL SYSTEM 810, ACL AND THE REAGENT SETS is GJA.

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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: GJA)

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.

K050817T-TEKR2 Diagnostics, Inc.K982209ACCUCLOT THROMBIN TIME REAGENT MODEL A8713/A4589Sigma Diagnostics, Inc.K970645BC THROMBIN REAGENTBehring Diagnostics, Inc.K925493BIOMERIEUX HEMOLAB THROMBICALCI-TESTBiomerieux Vitek, Inc.K930157TEST THROMBINBehring Diagnostics, Inc.K923220THROMBIN CLOT TIME TEST PROCEDUREMedical Laboratory Automation Systems, Inc.

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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