The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Lipase Sr Liquid Stable Reagent Set.
| Device ID | K885078 |
| 510k Number | K885078 |
| Device Name: | LIPASE SR LIQUID STABLE REAGENT SET |
| Classification | Olive Oil Emulsion (turbidimetric), Lipase |
| 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 | CET |
| CFR Regulation Number | 862.1465 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-08 |
| Decision Date | 1989-03-13 |