Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Btc Diagnostics, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
102 daysmedian FDA review time
225 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841545 | ENZYME IMMUNOASSAY FOR DETECTION HORM | Btc Diagnostics, Inc. | 1984-11-27 | 225 | 0 |
| K832905 | QUALITATIVE ENZYME IMMUNOASSAY-DETECT | Btc Diagnostics, Inc. | 1984-02-03 | 158 | 0 |
| K833710 | BTC URINE LH ASSAY | Btc Diagnostics, Inc. | 1984-01-30 | 102 | 0 |
| K831604 | HCG ACCU-STICK | Btc Diagnostics, Inc. | 1983-07-19 | 62 | 0 |
| K831125 | BTC URINE LCG ASSAY | Btc Diagnostics, Inc. | 1983-05-05 | 30 | 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