Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Preventive Diagnostics Corp. — Predicate Candidate Screening
18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
100 days90th percentile
18clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K840677 | HDL EZ-TZ3 CHOLESTEROL REAGENT KIT | Preventive Diagnostics Corp. | 1984-04-13 | 58 | 0 |
| K840676 | PDC HDL EZ-SEP CHOLESTEROL REAGENT | Preventive Diagnostics Corp. | 1984-04-04 | 49 | 0 |
| K840220 | HDL CHOLESTEROL AQUEOUS STANDARDS | Preventive Diagnostics Corp. | 1984-03-23 | 64 | 0 |
| K840218 | TRIGLYCERIDE AQUEOUS STANDARDS | Preventive Diagnostics Corp. | 1984-03-23 | 64 | 0 |
| K840278 | HDL CHOLESTEROL CONTROLS-LEVELS | Preventive Diagnostics Corp. | 1984-03-23 | 60 | 0 |
| K840217 | CHOLESTEROL AQUEOUS STANDARD | Preventive Diagnostics Corp. | 1984-03-23 | 64 | 0 |
| K840219 | TRIGLYCERIDE/CHOLESTEROL AQUEOUS | Preventive Diagnostics Corp. | 1984-03-23 | 64 | 0 |
| K840189 | TOTAL CHOLESTEROL REAGENT SET | Preventive Diagnostics Corp. | 1984-03-23 | 65 | 0 |
| K840991 | PRESERV BUFFERED GLYCEROL SALINE | Preventive Diagnostics Corp. | 1984-03-23 | 16 | 0 |
| K840968 | PRESERV TRANSPORT & CULTURE PACK | Preventive Diagnostics Corp. | 1984-03-23 | 17 | 0 |
| K840990 | PRESERV CARY BLAIR TRANSPORT PACK | Preventive Diagnostics Corp. | 1984-03-23 | 16 | 0 |
| K840087 | PRESERV GOMORI TRICHROME STAIN 125/500 | Preventive Diagnostics Corp. | 1984-02-10 | 31 | 0 |
| K833160 | HDL EZ-TAB | Preventive Diagnostics Corp. | 1984-02-09 | 146 | 0 |
| K834566 | PRESERV SAF FIXATIVE 15ML | Preventive Diagnostics Corp. | 1984-02-04 | 38 | 0 |
| K840086 | PRESERV MF FIXATIVE 15ML | Preventive Diagnostics Corp. | 1984-01-30 | 20 | 0 |
| K833431 | HDL EX-SEP PRECIPITATING REAGENT | Preventive Diagnostics Corp. | 1984-01-13 | 100 | 0 |
| K834412 | PRESERV PVA FIXATIVE 15ML-FORMALIN PK | Preventive Diagnostics Corp. | 1984-01-13 | 29 | 0 |
| K833660 | PRESERV PVA FIXATIVE -MALIN PACK | Preventive Diagnostics Corp. | 1983-11-28 | 41 | 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