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FDA 510(k)

OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT

K-Number: K963139 · 1997-02-06

ApplicantOlympus America, Inc.
Decision Date1997-02-06
Product CodeDDD
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS TRANSFERRIN 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 1997-02-06 under 510(k) number K963139. The device is classified under product code DDD. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT?

OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT is a medical device that received FDA 510(k) clearance on 1997-02-06. The listed applicant is Olympus America, Inc.. The 510(k) number is K963139.

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

OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT received FDA 510(k) clearance on 1997-02-06, under 510(k) number K963139.

Who is the listed applicant for OLYMPUS TRANSFERRIN 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 TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT?

The FDA product code for OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT is DDD.

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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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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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