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FDA 510(k)

OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT

K-Number: K962409 · 1996-10-18

ApplicantOlympus America, Inc.
Decision Date1996-10-18
Product CodeCZW
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT 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 1996-10-18 under 510(k) number K962409. The device is classified under product code CZW. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT?

OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT is a medical device that received FDA 510(k) clearance on 1996-10-18. The listed applicant is Olympus America, Inc.. The 510(k) number is K962409.

When did OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT receive FDA 510(k) clearance?

OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT received FDA 510(k) clearance on 1996-10-18, under 510(k) number K962409.

Who is the listed applicant for OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT?

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 C3 IMMUNOTURBIDIMETRIC REGENT?

The FDA product code for OLYMPUS C3 IMMUNOTURBIDIMETRIC REGENT is CZW.

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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: CZW)

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.

K100179SPAPLUSThe Binding Site Group , Ltd.K063150COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROLThermo Electron OYK061852DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL LOW, MEDIUM, HIGHDade Behring, Inc.K050665N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)Dade Behring, Inc.K042494VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND IIIOrtho-Clinical DiagnosticsK032796IBL C3D-CIC EIA TESTIbl GmbH

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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