The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Hdl-cholesterol Precipitating Reagent.
| Device ID | K883543 |
| 510k Number | K883543 |
| Device Name: | HDL-CHOLESTEROL PRECIPITATING REAGENT |
| Classification | Enzymatic Esterase--oxidase, Cholesterol |
| Applicant | MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Contact | Donna L Anderson |
| Correspondent | Donna L Anderson MEDICAL ANALYSIS SYSTEMS, INC. LINCOLN TECHNOLOGY PARK 542 FLYNN RD. Camarillo, CA 93012 |
| Product Code | CHH |
| CFR Regulation Number | 862.1175 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-19 |
| Decision Date | 1988-12-16 |