Photec Diagnostics, Inc.
Medical device manufacturer in Mahwah, NJ.
12510(k) clearances
0PMA approvals
0recalls
Device types
- DER Alpha-1-Lipoprotein, Antigen, Antiserum… 3
- CHH Enzymatic Esterase--Oxidase, Cholesterol 2
- MSJ Apolipoproteins 1
- LCA Radioimmunoassay, Theophylline 1
- JJE Analyzer, Chemistry (Photometric… 1
- KHQ Radioassay, Triiodothyronine Uptake 1
- LBS Ldl & Vldl Precipitation, Cholesterol Via… 1
- KLI Enzyme Immunoassay, Non-Radiolabeled, Total… 1
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K897169 | Quikread(R) Whole Blood Triglyceride Test KitCDT · Traditional | 02/23/1990SE |
| K896329 | D-Chem Total T4 Test Kit for Thyroxine Quantita.KLI · Traditional | 12/12/1989SE |
| K894057 | Quikread Whole Blood Hdl-Cholesterol Test KitLBS · Traditional | 08/31/1989SE |
| K892224 | D-Chem(Tm) T-Uptake Test Kit for T-Uptake DeterminKHQ · Traditional | 06/16/1989SE |
| K890267 | Quikread Chem. Analyzer & Choles. for Serum/PlasmaCHH · Traditional | 04/26/1989SE |
| K890027 | Quikread Chem. Analyzer & Choles. for Whole BloodCHH · Traditional | 04/26/1989SE |
| K882307 | D-ChemJJE · Traditional | 08/02/1988SE |
| K880291 | Theophylline Test Kit Ref. #A874799LCA · Traditional | 03/24/1988SE |
| K854875 | Apo-Screen Calibrator & Control Set for HDL Apo A1DER · Traditional | 01/24/1986SE |
| K853048 | Apo-Screen Test Set for Hdl-Apolipoptein A-1DER · Traditional | 08/28/1985SE |
| K853174 | Apo-Chrome Immunoassay Test Set for ApolipoproteinMSJ · Traditional | 08/22/1985SE |
| K851649 | Apo A-I Immunoassay Test Set for Apolipoprotein A1DER · Traditional | 06/05/1985SE |