Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Clinical Assays, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
94 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | Clinical Assays, Inc. | 1983-10-04 | 53 | 0 |
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | Clinical Assays, Inc. | 1983-10-04 | 53 | 0 |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | Clinical Assays, Inc. | 1983-10-04 | 53 | 0 |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | Clinical Assays, Inc. | 1982-12-28 | 36 | 0 |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | Clinical Assays, Inc. | 1982-12-22 | 47 | 0 |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | Clinical Assays, Inc. | 1982-06-24 | 22 | 0 |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | Clinical Assays, Inc. | 1982-06-22 | 64 | 0 |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | Clinical Assays, Inc. | 1981-09-24 | 45 | 0 |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1981-05-27 | 71 | 0 |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1981-04-23 | 15 | 0 |
| K801667 | GAMMA COAT(125 I) RUBELLA ANTIBODY | Clinical Assays, Inc. | 1980-10-23 | 94 | 0 |
| K791497 | PROSTATIC ACID RADIOIMMUNOASSAY TEST | Clinical Assays, Inc. | 1979-12-04 | 123 | 0 |
| K791079 | GAMMADAB (125 1) FOLATE RADIOASSAY KIT | Clinical Assays, Inc. | 1979-07-17 | 35 | 0 |
| K782109 | RIA KIT, GAMMACOAT | Clinical Assays, Inc. | 1979-01-26 | 38 | 0 |
| K781938 | RIA KIT, GAMMADAB ESTRIOL | Clinical Assays, Inc. | 1979-01-10 | 51 | 0 |
| K780934 | IN VITRO TOBRAMYCIN RIA KIT | Clinical Assays, Inc. | 1978-08-14 | 67 | 0 |
| K781235 | IV VITRO GAMMADAB T4 RIA KIT | Clinical Assays, Inc. | 1978-08-14 | 26 | 0 |
| K780854 | IN VITRO NEONATAL T4 | Clinical Assays, Inc. | 1978-07-27 | 66 | 0 |
| K780709 | IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST | Clinical Assays, Inc. | 1978-05-12 | 16 | 0 |
| K772017 | IN VITRO THEOPHYLLINE RIA TEST | Clinical Assays, Inc. | 1978-03-27 | 152 | 0 |
| K772109 | IN VITRO HUMAN TSH RIA TEST | Clinical Assays, Inc. | 1977-12-06 | 29 | 0 |
| K772111 | IN VITRO PHENOBARBITAL RIA TEST | Clinical Assays, Inc. | 1977-11-28 | 21 | 0 |
| K772110 | IN VITRO DIGOXIN RIA TEST | Clinical Assays, Inc. | 1977-11-22 | 15 | 0 |
| K772108 | IN VITRO T3 RIA TEST | Clinical Assays, Inc. | 1977-11-17 | 10 | 0 |
| K771597 | IN VITRO FOLATE RADIOASSAY KIT | Clinical Assays, Inc. | 1977-09-13 | 25 | 0 |
| K770702 | IN VITRO FERRITIN RIA TEST | Clinical Assays, Inc. | 1977-06-17 | 60 | 0 |
| K770480 | IN VITRO T-3 UPTAKE TEST | Clinical Assays, Inc. | 1977-04-06 | 26 | 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