Medical Device Manufacturer · US , Walker , MI

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

23 submissions · 23 cleared · Since 1977
23
Total
23
Cleared
0
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.

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

23 devices
1-23 of 23
Cleared May 15, 1979
GAMMA SMAC REAGENTS
K790578 · CIG
Chemistry · 49d
Cleared May 03, 1978
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
K780507 · CKC
Chemistry · 34d
Cleared Nov 22, 1977
CHLORIDE
K771832 · JFS
Chemistry · 62d
Cleared Nov 22, 1977
LACTATE DEHYDROGENASE
K771836 · CFJ
Chemistry · 62d
Cleared Nov 22, 1977
WETTING AGENTS
K771843
Chemistry · 62d
Cleared Nov 03, 1977
CREATININE
K771834 · CGX
Chemistry · 43d
Cleared Nov 03, 1977
SERUM IRON
K771838 · JIY
Chemistry · 43d
Cleared Nov 02, 1977
ALKALINE PHOSPHATASE
K771829 · CJE
Chemistry · 42d
Cleared Nov 02, 1977
INORGANIC PHOSPHORUS
K771835 · CEO
Chemistry · 42d
Cleared Nov 02, 1977
POTASSIUM
K771837 · CEM
Chemistry · 42d
Cleared Nov 02, 1977
SODIUM
K771839 · JGS
Chemistry · 42d
Cleared Oct 25, 1977
ALBUMIN
K771828 · CIX
Chemistry · 26d
Cleared Oct 25, 1977
BLOOD UREA NITROGEN BUN
K771830 · CDW
Chemistry · 34d
Cleared Oct 25, 1977
CALCIUM
K771831 · CIC
Chemistry · 34d
Cleared Oct 25, 1977
TOTAL PROTEIN
K771841 · CEK
Chemistry · 34d
Cleared Oct 25, 1977
URIC ACID
K771842 · CDH
Chemistry · 34d
Cleared Oct 25, 1977
WASH SOLUTIONS
K771844
Chemistry · 34d
Cleared Oct 19, 1977
TOTAL BILIRUBIN
K771840 · CIG
Chemistry · 28d
Cleared Oct 18, 1977
CHOLESTEROL
K771833 · CGO
Chemistry · 27d
Cleared Mar 16, 1977
SALONMAY BUSTLINE INCREASER
K770082 · MWZ
General & Plastic Surgery · 61d
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