Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biotest Diagnostics Corp. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
222 daysmedian FDA review time
301 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991650 | CMV BRITE TURBO KIT | Biotest Diagnostics Corp. | 1999-07-12 | 60 | 0 |
| K983839 | BIOTEST ANTI-EBV RECOMBINANT | Biotest Diagnostics Corp. | 1999-06-09 | 222 | 0 |
| K983841 | BIOTEST ANTI-EBV RECOMBINANT, EBNA IGG | Biotest Diagnostics Corp. | 1999-06-09 | 222 | 0 |
| K983842 | BIOTEST ANTI-EBV RECOMBINANT, EA IGM | Biotest Diagnostics Corp. | 1999-06-09 | 222 | 0 |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | Biotest Diagnostics Corp. | 1996-01-30 | 301 | 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