Company ยท US
Gamma Enterprises, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1979. Name variants (Inc, Corp, punctuation) are merged.
23510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 2 |
| CDH | Acid, Uric, Phosphotungstate Reduction | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CGO | Lieberman-Burchard/Abell-Kendall, Colorimetric, Cholesterol | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
| CKC | Vanillin Pyruvate, Alt/Sgpt | 1 |
| JFS | Coulometric, Chloride | 1 |
| JGS | Electrode, Ion Specific, Sodium | 1 |
| JHS | Differential Rate Kinetic Method, Cpk Or Isoenzymes | 1 |
| JIY | Photometric Method, Iron (Non-Heme) | 1 |
| KMS | Phenolphthalein Colorimetry, Carbon-Dioxide | 1 |
| MWZ | Expander, Breast, External | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 15, 1979 | K790578 | GAMMA SMAC REAGENTS Gamma Enterprises, Inc. | CIG |
| May 3, 1978 | K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE Gamma Enterprises, Inc. | CKC |
| May 3, 1978 | K780506 | CARBON DIOXIDE REAGENTS Gamma Enterprises, Inc. | KMS |
| May 3, 1978 | K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE Gamma Enterprises, Inc. | CIT |
| May 3, 1978 | K780504 | CREATINE PHOSPHOKINASE (CPK) Gamma Enterprises, Inc. | JHS |
| Nov 22, 1977 | K771843 | WETTING AGENTS Gamma Enterprises, Inc. | |
| Nov 22, 1977 | K771836 | LACTATE DEHYDROGENASE Gamma Enterprises, Inc. | CFJ |
| Nov 22, 1977 | K771832 | CHLORIDE Gamma Enterprises, Inc. | JFS |
| Nov 3, 1977 | K771838 | SERUM IRON Gamma Enterprises, Inc. | JIY |
| Nov 3, 1977 | K771834 | CREATININE Gamma Enterprises, Inc. | CGX |
| Nov 2, 1977 | K771839 | SODIUM Gamma Enterprises, Inc. | JGS |
| Nov 2, 1977 | K771837 | POTASSIUM Gamma Enterprises, Inc. | CEM |
| Nov 2, 1977 | K771835 | INORGANIC PHOSPHORUS Gamma Enterprises, Inc. | CEO |
| Nov 2, 1977 | K771829 | ALKALINE PHOSPHATASE Gamma Enterprises, Inc. | CJE |
| Oct 25, 1977 | K771844 | WASH SOLUTIONS Gamma Enterprises, Inc. | |
| Oct 25, 1977 | K771842 | URIC ACID Gamma Enterprises, Inc. | CDH |
| Oct 25, 1977 | K771841 | TOTAL PROTEIN Gamma Enterprises, Inc. | CEK |
| Oct 25, 1977 | K771831 | CALCIUM Gamma Enterprises, Inc. | CIC |
| Oct 25, 1977 | K771830 | BLOOD UREA NITROGEN BUN Gamma Enterprises, Inc. | CDW |
| Oct 25, 1977 | K771828 | ALBUMIN Gamma Enterprises, Inc. | CIX |
| Oct 19, 1977 | K771840 | TOTAL BILIRUBIN Gamma Enterprises, Inc. | CIG |
| Oct 18, 1977 | K771833 | CHOLESTEROL Gamma Enterprises, Inc. | CGO |
| Mar 16, 1977 | K770082 | SALONMAY BUSTLINE INCREASER Gamma Enterprises, Inc. | MWZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||