The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Valproic Acid, Immulite 2000 Valproic Acid, Catalog # Lkva1, Lkva5 & L2kva2, L2kva6.
| Device ID | K000005 |
| 510k Number | K000005 |
| Device Name: | IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 |
| Classification | Enzyme Immunoassay, Valproic Acid |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward M Levine |
| Correspondent | Edward M Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | LEG |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-03 |
| Decision Date | 2000-03-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964850 | K000005 | 000 |
| 00630414962290 | K000005 | 000 |