Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Reagent Tech. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
154 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K843302 | NEW ALLERG. COATED MICROFILTER WELL STRI | Diagnostic Reagent Tech. | 1984-10-04 | 42 | 0 |
| K832345 | POLYSTYRENE MICROTITER WELL IMMUNOSOR | Diagnostic Reagent Tech. | 1983-11-25 | 130 | 0 |
| K832344 | POLYSTYRENE MICROTITER PLATE IMMUNO- | Diagnostic Reagent Tech. | 1983-11-21 | 131 | 0 |
| K831984 | POLYSTYRENE MICRO-LITER PLATE-BIRCHTREE | Diagnostic Reagent Tech. | 1983-11-21 | 154 | 0 |
| K831496 | ALLERGEN IMMUNOSORBENTS IP SPECIFIC E | Diagnostic Reagent Tech. | 1983-08-08 | 90 | 0 |
| K831774 | LOGIPE A DATA REDUCSYSTEM IP SPECIFIC- | Diagnostic Reagent Tech. | 1983-07-18 | 46 | 0 |
| K830005 | IP SPECIFIC G | Diagnostic Reagent Tech. | 1983-06-02 | 150 | 0 |
| K830653 | POLYSTYRENE MICROTITER PLATE IMMUNOSORB | Diagnostic Reagent Tech. | 1983-04-08 | 38 | 0 |
| K830495 | POLYSTYRENE MICROTITER PLATE IMMUNOSOR | Diagnostic Reagent Tech. | 1983-04-05 | 48 | 0 |
| K821094 | IP SPECIFIC E | Diagnostic Reagent Tech. | 1982-05-07 | 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