The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Phenytoin, Immulite 2000 Phenytoin, Catalog # Lkpn1, Lkpn5 & L2kpn2, L2kpn6.
| Device ID | K000006 |
| 510k Number | K000006 |
| Device Name: | IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 |
| Classification | Enzyme Immunoassay, Diphenylhydantoin |
| 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 | DIP |
| CFR Regulation Number | 862.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-03 |
| Decision Date | 2000-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964492 | K000006 | 000 |
| 00630414961903 | K000006 | 000 |
| 00630414953410 | K000006 | 000 |