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

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

22 devices
1-22 of 22
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
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