The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Phenobarbital, Models Lkpb1, Lkpb5.
| Device ID | K000012 |
| 510k Number | K000012 |
| Device Name: | IMMULITE PHENOBARBITAL, MODELS LKPB1, LKPB5 |
| Classification | Enzyme Immunoassay, Phenobarbital |
| 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 | DLZ |
| CFR Regulation Number | 862.3660 [🔎] |
| 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 |
|---|---|---|
| 00630414964379 | K000012 | 000 |