Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gamma Enterprises, Inc. — Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
62 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K790578 | GAMMA SMAC REAGENTS | Gamma Enterprises, Inc. | 1979-05-15 | 49 | 0 |
| K780507 | SERUM GLUTAMIC-PYRUVIC TRANSAMINASE | Gamma Enterprises, Inc. | 1978-05-03 | 34 | 0 |
| K780505 | SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE | Gamma Enterprises, Inc. | 1978-05-03 | 34 | 0 |
| K780504 | CREATINE PHOSPHOKINASE (CPK) | Gamma Enterprises, Inc. | 1978-05-03 | 34 | 0 |
| K780506 | CARBON DIOXIDE REAGENTS | Gamma Enterprises, Inc. | 1978-05-03 | 34 | 0 |
| K771832 | CHLORIDE | Gamma Enterprises, Inc. | 1977-11-22 | 62 | 0 |
| K771836 | LACTATE DEHYDROGENASE | Gamma Enterprises, Inc. | 1977-11-22 | 62 | 0 |
| K771843 | WETTING AGENTS | Gamma Enterprises, Inc. | 1977-11-22 | 62 | 0 |
| K771838 | SERUM IRON | Gamma Enterprises, Inc. | 1977-11-03 | 43 | 0 |
| K771834 | CREATININE | Gamma Enterprises, Inc. | 1977-11-03 | 43 | 0 |
| K771829 | ALKALINE PHOSPHATASE | Gamma Enterprises, Inc. | 1977-11-02 | 42 | 0 |
| K771835 | INORGANIC PHOSPHORUS | Gamma Enterprises, Inc. | 1977-11-02 | 42 | 0 |
| K771839 | SODIUM | Gamma Enterprises, Inc. | 1977-11-02 | 42 | 0 |
| K771837 | POTASSIUM | Gamma Enterprises, Inc. | 1977-11-02 | 42 | 0 |
| K771828 | ALBUMIN | Gamma Enterprises, Inc. | 1977-10-25 | 26 | 0 |
| K771841 | TOTAL PROTEIN | Gamma Enterprises, Inc. | 1977-10-25 | 34 | 0 |
| K771842 | URIC ACID | Gamma Enterprises, Inc. | 1977-10-25 | 34 | 0 |
| K771844 | WASH SOLUTIONS | Gamma Enterprises, Inc. | 1977-10-25 | 34 | 0 |
| K771830 | BLOOD UREA NITROGEN BUN | Gamma Enterprises, Inc. | 1977-10-25 | 34 | 0 |
| K771831 | CALCIUM | Gamma Enterprises, Inc. | 1977-10-25 | 34 | 0 |
| K771840 | TOTAL BILIRUBIN | Gamma Enterprises, Inc. | 1977-10-19 | 28 | 0 |
| K771833 | CHOLESTEROL | Gamma Enterprises, Inc. | 1977-10-18 | 27 | 0 |
| K770082 | SALONMAY BUSTLINE INCREASER | Gamma Enterprises, Inc. | 1977-03-16 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda