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FDA 510(k)

OLYMPUS INORGANIC PHOSPHORUS REAGENT

K-Number: K944768 · 1995-03-24

ApplicantOlympus America, Inc.
Decision Date1995-03-24
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

OLYMPUS INORGANIC PHOSPHORUS 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 1995-03-24 under 510(k) number K944768. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS INORGANIC PHOSPHORUS REAGENT?

OLYMPUS INORGANIC PHOSPHORUS REAGENT is a medical device that received FDA 510(k) clearance on 1995-03-24. The listed applicant is Olympus America, Inc.. The 510(k) number is K944768.

When did OLYMPUS INORGANIC PHOSPHORUS REAGENT receive FDA 510(k) clearance?

OLYMPUS INORGANIC PHOSPHORUS REAGENT received FDA 510(k) clearance on 1995-03-24, under 510(k) number K944768.

Who is the listed applicant for OLYMPUS INORGANIC PHOSPHORUS 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 INORGANIC PHOSPHORUS REAGENT?

The FDA product code for OLYMPUS INORGANIC PHOSPHORUS REAGENT is CEO.

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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: CEO)

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K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K041643SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENTBeckman Coulter, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories Saic

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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