The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Dimension(r) Valproic (valp) Acid Method.
| Device ID | K982880 |
| 510k Number | K982880 |
| Device Name: | DIMENSION(R) VALPROIC (VALP) ACID METHOD |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rebecca S Ayash |
| Correspondent | Rebecca S Ayash DADE BEHRING, INC. BLDG. 500 MAIL BOX 514 P.O. BOX 6101 Newark, DE 19714 -6101 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-14 |
| Decision Date | 1998-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414596013 | K982880 | 000 |
| 00842768005718 | K982880 | 000 |