Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pro-Lab, Inc. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
168 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934383 | PROLEX (STREPTOCCAL GROUPING LATEX KIT) | Pro-Lab, Inc. | 1995-01-27 | 505 | 0 |
| K914419 | AMNIOTEST(TM) | Pro-Lab, Inc. | 1993-09-01 | 699 | 0 |
| K921421 | LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY | Pro-Lab, Inc. | 1992-07-28 | 126 | 0 |
| K903714 | E. COLI 0157 LATEX TEST | Pro-Lab, Inc. | 1991-01-24 | 163 | 0 |
| K894221 | ROSCO PYRR | Pro-Lab, Inc. | 1989-09-28 | 101 | 0 |
| K883996 | X-ACT LDC/IND | Pro-Lab, Inc. | 1988-10-12 | 22 | 0 |
| K883995 | X-ACT UREA/TDA | Pro-Lab, Inc. | 1988-10-12 | 22 | 0 |
| K871121 | PROTECT T.M. | Pro-Lab, Inc. | 1987-04-14 | 26 | 0 |
| K870117 | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Pro-Lab, Inc. | 1987-03-20 | 67 | 0 |
| K861142 | MASTER KIT B | Pro-Lab, Inc. | 1986-07-10 | 106 | 0 |
| K861889 | D'ALA RAPID TEST | Pro-Lab, Inc. | 1986-06-03 | 18 | 0 |
| K861888 | HIPPURATE HYDROLYSIS TEST | Pro-Lab, Inc. | 1986-06-03 | 18 | 0 |
| K850246 | MASTER KIT A | Pro-Lab, Inc. | 1985-04-09 | 77 | 0 |
| K850302 | SUPLEX & SUPLEX DILUENT | Pro-Lab, Inc. | 1985-03-22 | 59 | 0 |
| K850299 | C.N.V.T. | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850307 | CAMPYLOBACTER SUPPLEMENT-BLASER/WANG | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850300 | MUCOLYSE | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850308 | C.L.A.T. | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850306 | CAMPYLOBACTER SUPPLEMENT -SKIRROW | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850301 | YEAST DIALYSATE | Pro-Lab, Inc. | 1985-03-20 | 57 | 0 |
| K850072 | CUSTOM OPEN HEART TRAY | Pro-Lab, Inc. | 1985-03-15 | 65 | 0 |
| K843813 | INTRAVENOUS START KIT | Pro-Lab, Inc. | 1984-12-05 | 68 | 0 |
| K842404 | DRESSING CHANGE TRAY STERILE 5002 | Pro-Lab, Inc. | 1984-12-04 | 168 | 0 |
| K843627 | VENESECTION TRAY, ADULT 6050 | Pro-Lab, Inc. | 1984-12-04 | 81 | 0 |
| K843525 | SUTURE TRAY | Pro-Lab, Inc. | 1984-11-05 | 59 | 0 |
| K843982 | O.B. BASIN SET | Pro-Lab, Inc. | 1984-10-31 | 20 | 0 |
| K842405 | DR. GOULD HAND PACK SUSTOM STERIL | Pro-Lab, Inc. | 1984-08-15 | 57 | 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