The following data is part of a premarket notification filed by Medical Analysis Systems, Inc. with the FDA for Reflab(tm) Br Syst Pack Liq Reag, Apolipoprotein B.
| Device ID | K912749 |
| 510k Number | K912749 |
| Device Name: | REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B |
| Classification | Apolipoproteins |
| 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 | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-21 |
| Decision Date | 1991-09-23 |