The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Om-ma, Models Lkopz, Lkop1, Lkop5.
| Device ID | K981297 |
| 510k Number | K981297 |
| Device Name: | IMMULITE OM-MA, MODELS LKOPZ, LKOP1, LKOP5 |
| Classification | Test, Epithelial Ovarian Tumor-associated Antigen (ca125) |
| 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 | LTK |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-08 |
| Decision Date | 1998-09-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964331 | K981297 | 000 |
| 00630414954127 | K981297 | 000 |