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FDA 510(k)

OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT

K-Number: K950900 · 1995-03-27

ApplicantOlympus America, Inc.
Decision Date1995-03-27
Product CodeCFQ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT 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 1995-03-27 under 510(k) number K950900. The device is classified under product code CFQ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT?

OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT is a medical device that received FDA 510(k) clearance on 1995-03-27. The listed applicant is Olympus America, Inc.. The 510(k) number is K950900.

When did OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT receive FDA 510(k) clearance?

OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT received FDA 510(k) clearance on 1995-03-27, under 510(k) number K950900.

Who is the listed applicant for OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT?

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 OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT?

The FDA product code for OLYMPUS IGM IMMUNOTURBIDIMETRIC REAGENT is CFQ.

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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: CFQ)

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.

K981786IGA MININEPH ANTISERUMThe Binding Site, Ltd.K990551IGG FLEX REAGENT CARTRIDGEDade Behring, Inc.K990552IMMUNOGLOBULIN A TEST SYSTEMDade Behring, Inc.K990553IGM FLEX REAGENT CARTRIDGEDade Behring, Inc.K951055OLYMPUS IGA IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.K951013OLYMPUS IGG IMMUNOTURBIDIMETRIC REAGENTOlympus America, 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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