The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Afp, Model Lkapi, Lkap5, Immulite 2000 Afp, Model L2kap2.
| Device ID | K983263 |
| 510k Number | K983263 |
| Device Name: | IMMULITE AFP, MODEL LKAPI, LKAP5, IMMULITE 2000 AFP, MODEL L2KAP2 |
| Classification | Kit, Test,alpha-fetoprotein For Testicular Cancer |
| 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 | LOJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-17 |
| Decision Date | 1998-12-07 |
| Summary: | summary |