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FDA 510(k)

OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT

K-Number: K953437 · 1995-10-20

ApplicantOlympus America, Inc.
Decision Date1995-10-20
Product CodeGTQ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

OLYMPUS ANTI-STERPTOLYSIN O 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 1995-10-20 under 510(k) number K953437. The device is classified under product code GTQ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT?

OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT is a medical device that received FDA 510(k) clearance on 1995-10-20. The listed applicant is Olympus America, Inc.. The 510(k) number is K953437.

When did OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT receive FDA 510(k) clearance?

OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT received FDA 510(k) clearance on 1995-10-20, under 510(k) number K953437.

Who is the listed applicant for OLYMPUS ANTI-STERPTOLYSIN O 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 ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT?

The FDA product code for OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT is GTQ.

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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: GTQ)

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.

K052645VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;Ortho-Clinical DiagnosticsK915742TURBIQUANT ASLBehring Diagnostics, Inc.K926236BECKMAN ANTI-STREPTOLYSIN O KITBeckman Instruments, Inc.K924247ACCUTEX ASO LATEX TESTJ.S. Medical Assoc.K922723TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROLSimplicity Diagnostics, Inc.K915053BECKMAN ANTISTREPTOLYSIN O, MODIFICATIONBeckman Instruments, 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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