The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Valproic Acid (v-pa) Reagent.
| Device ID | K031870 |
| 510k Number | K031870 |
| Device Name: | SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Mary Beth Tang |
| Correspondent | Mary Beth Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-17 |
| Decision Date | 2003-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222178 | K031870 | 000 |