Medical Device Manufacturer · US , Walker , MI

Gamma Enterprises, Inc. - FDA 510(k) Cleared Devices

23 submissions · 23 cleared · Since 1977

Recent clearances: GAMMA SMAC REAGENTS, CREATINE PHOSPHOKINASE (CPK), SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE

Total

Cleared

Denied

Gamma Enterprises, Inc. has 23 FDA 510(k) cleared chemistry devices. Based in Walker, US.

Historical record: 23 cleared submissions from 1977 to 1979.

Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.

Gamma Enterprises, Inc. is one of 14878 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Gamma Enterprises, Inc.

23 devices

1-12 of 23

CREATINE PHOSPHOKINASE (CPK)

K780504 · JHS

Chemistry · 34d

Cleared May 03, 1978

SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE

K780505 · CIT

Chemistry · 34d

Cleared May 03, 1978

CARBON DIOXIDE REAGENTS

K780506 · KMS

Chemistry · 34d

Cleared May 03, 1978

SERUM GLUTAMIC-PYRUVIC TRANSAMINASE

LACTATE DEHYDROGENASE

Gamma Enterprises, Inc. - FDA 510(k) Cleared Devices

FDA 510(k) Regulatory Record - Gamma Enterprises, Inc.

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