Company ยท US
Photec Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 1990. Name variants (Inc, Corp, punctuation) are merged.
12510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DER | Alpha-1-Lipoprotein, Antigen, Antiserum, Control | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 1 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 1 |
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | 1 |
| LCA | Radioimmunoassay, Theophylline | 1 |
| MSJ | Apolipoproteins | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 23, 1990 | K897169 | QUIKREAD(R) WHOLE BLOOD TRIGLYCERIDE TEST KIT Photec Diagnostics, Inc. | CDT |
| Dec 12, 1989 | K896329 | D-CHEM TOTAL T4 TEST KIT FOR THYROXINE QUANTITA. Photec Diagnostics, Inc. | KLI |
| Aug 31, 1989 | K894057 | QUIKREAD WHOLE BLOOD HDL-CHOLESTEROL TEST KIT Photec Diagnostics, Inc. | LBS |
| Jun 16, 1989 | K892224 | D-CHEM(TM) T-UPTAKE TEST KIT FOR T-UPTAKE DETERMIN Photec Diagnostics, Inc. | KHQ |
| Apr 26, 1989 | K890267 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR SERUM/PLASMA Photec Diagnostics, Inc. | CHH |
| Apr 26, 1989 | K890027 | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD Photec Diagnostics, Inc. | CHH |
| Aug 2, 1988 | K882307 | D-CHEM Photec Diagnostics, Inc. | JJE |
| Mar 24, 1988 | K880291 | THEOPHYLLINE TEST KIT REF. #A874799 Photec Diagnostics, Inc. | LCA |
| Jan 24, 1986 | K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 Photec Diagnostics, Inc. | DER |
| Aug 28, 1985 | K853048 | APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1 Photec Diagnostics, Inc. | DER |
| Aug 22, 1985 | K853174 | APO-CHROME IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN Photec Diagnostics, Inc. | MSJ |
| Jun 5, 1985 | K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 Photec Diagnostics, Inc. | DER |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||