The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Lx Systems Apolipoprotein (apoa And Apob) Reagents.
| Device ID | K970314 |
| 510k Number | K970314 |
| Device Name: | SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS |
| Classification | Apolipoproteins |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Kathleen M Jaker |
| Correspondent | Kathleen M Jaker BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | MSJ |
| CFR Regulation Number | 862.1475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-24 |
| Decision Date | 1997-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590232047 | K970314 | 000 |
| 15099590231637 | K970314 | 000 |
| 15099590229931 | K970314 | 000 |