The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Apolipoprotein Test System.
| Device ID | K921037 |
| 510k Number | K921037 |
| Device Name: | APOLIPOPROTEIN TEST SYSTEM |
| Classification | Apolipoproteins |
| Applicant | BAXTER DIAGNOSTICS, INC. P.O. BOX 25101 Santa Ana, CA 92799 |
| Contact | Scott Beggins |
| Correspondent | Scott Beggins BAXTER DIAGNOSTICS, INC. P.O. BOX 25101 Santa Ana, CA 92799 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-04 |
| Decision Date | 1992-05-22 |