The following data is part of a premarket notification filed by Bacton Assay Systems, Inc. with the FDA for Bacton(tm), Auto-apo A-1 Reagent.
| Device ID | K921795 |
| 510k Number | K921795 |
| Device Name: | BACTON(TM), AUTO-APO A-1 REAGENT |
| Classification | Apolipoproteins |
| Applicant | BACTON ASSAY SYSTEMS, INC. 772-A TWIN OAKS VALLEY RD. San Marcos, CA 92069 |
| Contact | George L Liggins |
| Correspondent | George L Liggins BACTON ASSAY SYSTEMS, INC. 772-A TWIN OAKS VALLEY RD. San Marcos, CA 92069 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-10 |
| Decision Date | 1992-06-23 |