The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Epo, Model #'s Lkepz & Lkep1.
| Device ID | K983203 |
| 510k Number | K983203 |
| Device Name: | IMMULITE EPO, MODEL #'S LKEPZ & LKEP1 |
| Classification | Assay, Erythropoietin |
| 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 | GGT |
| CFR Regulation Number | 864.7250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-14 |
| Decision Date | 1999-07-12 |
| Summary: | summary |