The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Valproic Acid (vpa) Reagent.
| Device ID | K961256 |
| 510k Number | K961256 |
| Device Name: | SYNCHRON SYSTEMS VALPROIC ACID (VPA) REAGENT |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Contact | Paul Trujillo |
| Correspondent | Paul Trujillo BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92622 -8000 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-01 |
| Decision Date | 1996-05-15 |
| Summary: | summary |