The following data is part of a premarket notification filed by Photec Diagnostics, Inc. with the FDA for Quikread Chem. Analyzer & Choles. For Whole Blood.
| Device ID | K890027 |
| 510k Number | K890027 |
| Device Name: | QUIKREAD CHEM. ANALYZER & CHOLES. FOR WHOLE BLOOD |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
| Contact | Barry Mcdonald |
| Correspondent | Barry Mcdonald PHOTEC DIAGNOSTICS, INC. 101 EAST MAIN ST. Little Falls, NJ 07424 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-04 |
| Decision Date | 1989-04-26 |