Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Photec Diagnostics, Inc. — Predicate Candidate Screening
12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
112 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | Photec Diagnostics, Inc. | 1990-02-23 | 57 | 0 |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | Photec Diagnostics, Inc. | 1989-12-12 | 40 | 0 |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | Photec Diagnostics, Inc. | 1989-08-31 | 85 | 0 |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | Photec Diagnostics, Inc. | 1989-06-16 | 74 | 0 |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | Photec Diagnostics, Inc. | 1989-04-26 | 112 | 0 |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | Photec Diagnostics, Inc. | 1989-04-26 | 112 | 0 |
| K882307 | D-CHEM | Photec Diagnostics, Inc. | 1988-08-02 | 60 | 0 |
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | Photec Diagnostics, Inc. | 1988-03-24 | 59 | 0 |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | 1986-01-24 | 51 | 0 |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | Photec Diagnostics, Inc. | 1985-08-28 | 40 | 0 |
| K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN | Photec Diagnostics, Inc. | 1985-08-22 | 23 | 0 |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | 1985-06-05 | 44 | 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