Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Intl. Bioclinical, Inc. — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
119 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K913187 | INNOFLUOR(TM) DIGITOXIN REAGENT SET | Intl. Bioclinical, Inc. | 1991-09-23 | 67 | 0 |
| K913186 | INNOFLUOR(TM) DIGITOXIN CALIBRATOR SET | Intl. Bioclinical, Inc. | 1991-08-30 | 43 | 0 |
| K911688 | INNOFLUOR(TM) VALPROIC ACID REAGENT SET | Intl. Bioclinical, Inc. | 1991-07-05 | 80 | 0 |
| K911466 | INNOFLUOR VALPROIC ACID CALIBRATOR SET | Intl. Bioclinical, Inc. | 1991-05-23 | 50 | 0 |
| K883533 | ABC FP ANALYZER | Intl. Bioclinical, Inc. | 1988-12-15 | 119 | 0 |
| K864156 | PROGESTERONE SYSTEM BY EIA | Intl. Bioclinical, Inc. | 1986-11-24 | 32 | 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