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FDA 510(k)

INORGANIC PHOSPHORUS

K-Number: K771835 · 1977-11-02

ApplicantGamma Enterprises, Inc.
Decision Date1977-11-02
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

INORGANIC PHOSPHORUS is the device name listed in this FDA 510(k) record. The listed applicant is Gamma Enterprises, Inc.. It received FDA 510(k) clearance on 1977-11-02 under 510(k) number K771835. 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 INORGANIC PHOSPHORUS?

INORGANIC PHOSPHORUS is a medical device that received FDA 510(k) clearance on 1977-11-02. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K771835.

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

INORGANIC PHOSPHORUS received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771835.

Who is the listed applicant for INORGANIC PHOSPHORUS?

The FDA 510(k) record lists Gamma Enterprises, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INORGANIC PHOSPHORUS?

The FDA product code for INORGANIC PHOSPHORUS is CEO.

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Other records listing Gamma Enterprises, 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.

K790578GAMMA SMAC REAGENTSK780507SERUM GLUTAMIC-PYRUVIC TRANSAMINASEK780506CARBON DIOXIDE REAGENTSK780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780504CREATINE PHOSPHOKINASE (CPK)K771836LACTATE DEHYDROGENASE

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Related Devices (Code: CEO)

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.

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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