The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Turbo Hcg, Models Lskcg1, Lskcg5.
| Device ID | K994085 |
| 510k Number | K994085 |
| Device Name: | IMMULITE TURBO HCG, MODELS LSKCG1, LSKCG5 |
| Classification | System, Test, Human Chorionic Gonadotropin |
| 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 | DHA |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-03 |
| Decision Date | 2000-01-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964898 | K994085 | 000 |