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FDA 510(k)

OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT

K-Number: K954537 · 1996-02-14

ApplicantOlympus America, Inc.
Decision Date1996-02-14
Product CodeDCN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS C-REACTIVE PROTEIN 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 1996-02-14 under 510(k) number K954537. The device is classified under product code DCN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT?

OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT is a medical device that received FDA 510(k) clearance on 1996-02-14. The listed applicant is Olympus America, Inc.. The 510(k) number is K954537.

When did OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT receive FDA 510(k) clearance?

OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT received FDA 510(k) clearance on 1996-02-14, under 510(k) number K954537.

Who is the listed applicant for OLYMPUS C-REACTIVE PROTEIN 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 C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT?

The FDA product code for OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT is DCN.

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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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