The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Valproic Acid (vpa) Reagent.
| Device ID | K981403 |
| 510k Number | K981403 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM VALPROIC ACID (VPA) REAGENT |
| Classification | Calibrators, Drug Mixture |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-104 Brea, CA 92621 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-104 Brea, CA 92621 |
| Product Code | DKB |
| CFR Regulation Number | 862.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-17 |
| Decision Date | 1998-05-08 |
| Summary: | summary |