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FDA 510(k)

B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM

K-Number: K991136 · 1999-05-11

ApplicantOlympus America, Inc.
Decision Date1999-05-11
Product CodeJZG
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 1999-05-11 under 510(k) number K991136. 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 B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM?

B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1999-05-11. The listed applicant is Olympus America, Inc.. The 510(k) number is K991136.

When did B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM receive FDA 510(k) clearance?

B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM received FDA 510(k) clearance on 1999-05-11, under 510(k) number K991136.

Who is the listed applicant for B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM?

The FDA 510(k) record lists Olympus America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM?

The FDA product code for B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM is JZG.

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Other records listing Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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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