Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Diagnostic, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
50 daysmedian FDA review time
96 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K841853 | PREG-BETA ONE HOUR TUBE TEST | Intl. Diagnostic, Inc. | 1984-06-22 | 50 | 0 |
| K840833 | PREG BETA BLUS SLIDE | Intl. Diagnostic, Inc. | 1984-05-30 | 96 | 0 |
| K834584 | NABI CRP-Q.S. TEST | Intl. Diagnostic, Inc. | 1984-02-27 | 60 | 0 |
| K840005 | NABI RF-Q.S. TEST | Intl. Diagnostic, Inc. | 1984-02-13 | 40 | 0 |
| K802343 | PREGNA B-ANTI HUMAN CHORIONIC GONADOTRO | Intl. Diagnostic, Inc. | 1980-10-10 | 14 | 0 |
| K780321 | PREGNANCY TEST KIT, OVER-THE-COUNTER | Intl. Diagnostic, Inc. | 1978-04-04 | 39 | 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