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 |