Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Gamma Biologicals, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
64 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864207 | DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO | Gamma Biologicals, Inc. | 1986-12-03 | 37 | 0 |
| K861016 | GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS | Gamma Biologicals, Inc. | 1986-04-18 | 31 | 0 |
| K832473 | GAMMA SLIDE TEST FOR PREGNANCY | Gamma Biologicals, Inc. | 1983-08-16 | 21 | 0 |
| K820647 | GAMMA FETAL BLEED SCREENING TEST | Gamma Biologicals, Inc. | 1982-05-12 | 64 | 0 |
| K820072 | FE-CULT PLUS | Gamma Biologicals, Inc. | 1982-03-04 | 51 | 0 |
| K813342 | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION | Gamma Biologicals, Inc. | 1982-03-04 | 99 | 0 |
| K811752 | FE-CULT PLUS | Gamma Biologicals, Inc. | 1981-11-02 | 133 | 0 |
| K802533 | GAMMA LEWIS BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | 1980-11-12 | 28 | 0 |
| K802534 | GAMMA PI BLOOD GROUP SUBSTANCE | Gamma Biologicals, Inc. | 1980-11-12 | 28 | 0 |
| K800658 | RST-SERIES CONTROL | Gamma Biologicals, Inc. | 1980-04-16 | 21 | 0 |
| K792582 | POLY-LEC SYSTEM | Gamma Biologicals, Inc. | 1980-01-16 | 33 | 0 |
| K792583 | GAMMA ARACHIS HYPOGEA LECTIN | Gamma Biologicals, Inc. | 1980-01-16 | 33 | 0 |
| K790973 | LO-ION | Gamma Biologicals, Inc. | 1979-06-15 | 23 | 0 |
| K760034 | TEST, STREP, LATEX SLIDE | Gamma Biologicals, Inc. | 1976-08-11 | 58 | 0 |
| K760098 | REAGENT, VDRL | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 0 |
| K760096 | REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 0 |
| K760032 | TEST, MONO., DIFFERENTIAL SLIDE | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 0 |
| K760097 | FEBRILE ANTIGENS & CONTROL SERUMS | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 0 |
| K760033 | TEST, ANTIBODIES FOR GRP A, LATEX SLIDE | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 0 |
| K760036 | TEST, LATEX SLIDE, RHEUMATOID FACTOR | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 0 |
| K760035 | TEST, C-REATIVE PROTEIN, LATEX SLIDE | Gamma Biologicals, Inc. | 1976-08-03 | 50 | 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