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FDA 510(k)

IL TEST BETA-2MICROGLOBULIN

K-Number: K943686 · 1995-05-15

ApplicantInstrumentation Laboratory CO
Decision Date1995-05-15
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IL TEST BETA-2MICROGLOBULIN 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 1995-05-15 under 510(k) number K943686. The device is classified under product code JZG. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IL TEST BETA-2MICROGLOBULIN?

IL TEST BETA-2MICROGLOBULIN is a medical device that received FDA 510(k) clearance on 1995-05-15. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K943686.

When did IL TEST BETA-2MICROGLOBULIN receive FDA 510(k) clearance?

IL TEST BETA-2MICROGLOBULIN received FDA 510(k) clearance on 1995-05-15, under 510(k) number K943686.

Who is the listed applicant for IL TEST BETA-2MICROGLOBULIN?

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 BETA-2MICROGLOBULIN?

The FDA product code for IL TEST BETA-2MICROGLOBULIN is JZG.

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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: JZG)

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.

K161297Beta-2-MicroglobulinBeckman Coulter Ireland, Inc.K122066HUMAN BETA-2 MICROGLOBULIN URINE KIT FOR USE ON THE SPAPLUSThe Binding Site Group , Ltd.K110874ADVIA CHEMISTRY REAGENTS, AND ADVIA CHEMISTRY B2-MICROGLOBULIN CALIBRATORSiemens Healthcare Diagnostics, Inc.K083289HUMAN BETA-2 MICROGLOBULIN KITThe Binding Site, Ltd.K083463DIMENSION VISTA BETA 2 MICROGLOBULIN, DIMENSION VISTA PROTEIN 1 CALIBRATOR, DIMENSION VISTA PROTEIN 1 CONTROL MSiemens Healthcare DiagnosticsK072078QUANTIA BETA-2 MICROGLOBULIN, MODEL: 302822307Biokit, S.A.

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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