The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite 2500 Automated Immunoassay Analyzer.
| Device ID | K033234 |
| 510k Number | K033234 |
| Device Name: | IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER |
| Classification | System, Test, Human Chorionic Gonadotropin |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Edward Levine |
| Correspondent | Edward Levine DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | DHA |
| Subsequent Product Code | JJE |
| Subsequent Product Code | JLW |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-06 |
| Decision Date | 2003-12-12 |
| Summary: | summary |