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FDA 510(k)

IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)

K-Number: K990302 · 1999-04-08

ApplicantInstrumentation Laboratory CO
Decision Date1999-04-08
Product CodeGIR
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) 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 1999-04-08 under 510(k) number K990302. The device is classified under product code GIR. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)?

IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) is a medical device that received FDA 510(k) clearance on 1999-04-08. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K990302.

When did IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) receive FDA 510(k) clearance?

IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) received FDA 510(k) clearance on 1999-04-08, under 510(k) number K990302.

Who is the listed applicant for IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)?

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 LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)?

The FDA product code for IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA) is GIR.

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Other records listing Instrumentation Laboratory CO as applicant

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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: GIR)

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.

K110031HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRMInstrumentation Laboratory COK083878LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LAR2 Diagnostics, Inc.K061805STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRMDiagnostica Stago, Inc.K000527ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094Sigma Diagnostics, Inc.K000528ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119Sigma Diagnostics, Inc.K990580CRYOCHECK LA SURE, MODEL SUR25-10Precision Biologic

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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