The following data is part of a premarket notification filed by Diagnostic Products Corporation with the FDA for Immulite/immulite 1000 Turbo Intact Pth.
| Device ID | K053533 |
| 510k Number | K053533 |
| Device Name: | IMMULITE/IMMULITE 1000 TURBO INTACT PTH |
| Classification | Radioimmunoassay, Parathyroid Hormone |
| Applicant | DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Contact | Deborah L Morris |
| Correspondent | Deborah L Morris DIAGNOSTIC PRODUCTS CORPORATION 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Product Code | CEW |
| CFR Regulation Number | 862.1545 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-19 |
| Decision Date | 2006-02-03 |
| Summary: | summary |