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FDA 510(k)

SERUM GLUTAMIC-PYRUVIC TRANSAMINASE

K-Number: K780507 · 1978-05-03

ApplicantGamma Enterprises, Inc.
Decision Date1978-05-03
Product CodeCKC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SERUM GLUTAMIC-PYRUVIC TRANSAMINASE 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 1978-05-03 under 510(k) number K780507. The device is classified under product code CKC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERUM GLUTAMIC-PYRUVIC TRANSAMINASE?

SERUM GLUTAMIC-PYRUVIC TRANSAMINASE is a medical device that received FDA 510(k) clearance on 1978-05-03. The listed applicant is Gamma Enterprises, Inc.. The 510(k) number is K780507.

When did SERUM GLUTAMIC-PYRUVIC TRANSAMINASE receive FDA 510(k) clearance?

SERUM GLUTAMIC-PYRUVIC TRANSAMINASE received FDA 510(k) clearance on 1978-05-03, under 510(k) number K780507.

Who is the listed applicant for SERUM GLUTAMIC-PYRUVIC TRANSAMINASE?

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 SERUM GLUTAMIC-PYRUVIC TRANSAMINASE?

The FDA product code for SERUM GLUTAMIC-PYRUVIC TRANSAMINASE is CKC.

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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 REAGENTSK780505SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASEK780506CARBON DIOXIDE REAGENTSK780504CREATINE PHOSPHOKINASE (CPK)K771836LACTATE DEHYDROGENASEK771832CHLORIDE

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Related Devices (Code: CKC)

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.

K832791SERAYZER ALT/SGPT REAGENT STRIPSMiles Laboratories, Inc.

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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