Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intracel Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
166 daysmedian FDA review time
827 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003204 | BARTELS VIRAL RESPIRATORY SCREENING AND IDENTIFICATION KIT | Intracel Corp. | 2000-11-07 | 25 | 0 |
| K991074 | BARTELS LEGIONELLA URINARY ANTIGEN ELISA TEST | Intracel Corp. | 1999-12-21 | 265 | 1 |
| K990664 | PRIMA SYSTEM - OLD, BARTELS ELISA - NEW | Intracel Corp. | 1999-03-31 | 30 | 0 |
| K982311 | BARTELS CINAKIT CMV ANTIGENEMIA | Intracel Corp. | 1998-12-14 | 166 | 0 |
| K933878 | ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT | Intracel Corp. | 1995-11-14 | 827 | 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