Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biorent Diagnostic, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
27 daysmedian FDA review time
35 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K832747 | ALBUMIN REAGENT SET | Biorent Diagnostic, Inc. | 1983-10-14 | 60 | 0 |
| K823211 | CK-UV REAGENT | Biorent Diagnostic, Inc. | 1982-11-22 | 25 | 0 |
| K823060 | HEMOGLOBIN REAGENT | Biorent Diagnostic, Inc. | 1982-11-22 | 35 | 0 |
| K822494 | OPTIMIZED UV-GPT REAGENT SET | Biorent Diagnostic, Inc. | 1982-09-21 | 34 | 0 |
| K822493 | OPTIMIZED UV-GOT REAGENT SET | Biorent Diagnostic, Inc. | 1982-09-21 | 34 | 0 |
| K822492 | OPTIMIZED UV-LDH REAGENT SET | Biorent Diagnostic, Inc. | 1982-09-17 | 30 | 0 |
| K820768 | COLORIMETRIC LDH REAGENT SET | Biorent Diagnostic, Inc. | 1982-04-14 | 23 | 0 |
| K820632 | COLORIMETRIC URIC ACID REAGENT SET | Biorent Diagnostic, Inc. | 1982-03-25 | 17 | 0 |
| K813555 | GLUCOSE ENZYME-COLOR REAGENT SET | Biorent Diagnostic, Inc. | 1982-01-18 | 27 | 0 |
| K813244 | UV URIC ACID DETERMINATION | Biorent Diagnostic, Inc. | 1981-12-08 | 20 | 0 |
| K811760 | CHOLESTEROL DETERMINATION | Biorent Diagnostic, Inc. | 1981-07-10 | 18 | 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