Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Remel, L.P. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
101 daysmedian FDA review time
260 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972359 | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN | Remel, L.P. | 1997-08-28 | 64 | 0 |
| K964315 | REMEL STAPH LATEX KIT | Remel, L.P. | 1997-02-07 | 101 | 0 |
| K964421 | REMEL MEROPENEM 10UG SUSCEPTIBILITY DISK | Remel, L.P. | 1996-12-06 | 66 | 0 |
| K961046 | 10B ARGININE BROTH | Remel, L.P. | 1996-09-18 | 187 | 0 |
| K955143 | RPR LIQUID CONTROLS | Remel, L.P. | 1996-07-30 | 260 | 0 |
| K955136 | RPR CARD TEST KIT | Remel, L.P. | 1996-07-29 | 259 | 0 |
| K961818 | GENTAMICIN DISK (120MCG) | Remel, L.P. | 1996-07-10 | 61 | 0 |
| K961819 | STREPTOMYCIN DISK (300MCG) | Remel, L.P. | 1996-07-10 | 61 | 0 |
| K960313 | MUELLER HINTON AGAR WITH 2% NACI | Remel, L.P. | 1996-03-25 | 63 | 0 |
| K954986 | GC BASE W/ 1% GCHI | Remel, L.P. | 1996-02-16 | 108 | 1 |
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