The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Third Generation (modification).
| Device ID | K940006 |
| 510k Number | K940006 |
| Device Name: | IMMULITE THIRD GENERATION (MODIFICATION) |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch, Pharm.d., Ph.d |
| Correspondent | Kenneth B Asarch, Pharm.d., Ph.d DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-01-06 |
| Decision Date | 1994-12-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414964775 | K940006 | 000 |
| 00630414964768 | K940006 | 000 |