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FDA 510(k)

POTASSIUM

K-Number: K771837 · 1977-11-02

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

Device Summary

POTASSIUM 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 K771837. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POTASSIUM?

POTASSIUM 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 K771837.

When did POTASSIUM receive FDA 510(k) clearance?

POTASSIUM received FDA 510(k) clearance on 1977-11-02, under 510(k) number K771837.

Who is the listed applicant for POTASSIUM?

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 POTASSIUM?

The FDA product code for POTASSIUM is CEM.

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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: CEM)

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.

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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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