Photec Diagnostics, Inc.: FDA clearances and approvals
Photec Diagnostics, Inc. has 12 FDA 510(k) clearances (first 1985, latest 1990), across 9 product codes in 3 review panels. Median 510(k) review time: 58 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 3 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 | 1 |
| LCA | Radioimmunoassay, Theophylline | 1 | 1 |
| MSJ | Apolipoproteins | 1 | 1 |
Review panels
- Clinical Chemistry (8)
- Immunology (3)
- Clinical Toxicology (1)
Most recent Photec Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT | CDT | 1990-02-23 | 57 |
| K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. | KLI | 1989-12-12 | 40 |
| K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT | LBS | 1989-08-31 | 85 |
| K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN | KHQ | 1989-06-16 | 74 |
| K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA | CHH | 1989-04-26 | 112 |
| K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD | CHH | 1989-04-26 | 112 |
| K882307 | D-CHEM | JJE | 1988-08-02 | 60 |
| K880291 | THEOPHYLLINE TEST KIT REF. #A874799 | LCA | 1988-03-24 | 59 |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | DER | 1986-01-24 | 51 |
| K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 | DER | 1985-08-28 | 40 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Photec Diagnostics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Photec Diagnostics, Inc. have?
Photec Diagnostics, Inc. has 12 FDA 510(k) clearances (first 1985, latest 1990), across 9 product codes in 3 review panels.
How long does FDA take to clear Photec Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Photec Diagnostics, Inc.'s cleared 510(k)s is 58 days.
What devices does Photec Diagnostics, Inc. make?
Its most frequent FDA product codes are DER (Alpha-1-Lipoprotein, Antigen, Antiserum, Control, 3); CHH (Enzymatic Esterase--Oxidase, Cholesterol, 2); CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides, 1).
Has Photec Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Photec Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 12 Photec Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DER, Photec Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.