The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Free T3.
| Device ID | K974634 |
| 510k Number | K974634 |
| Device Name: | IMMULITE FREE T3 |
| Classification | Radioimmunoassay, Total Triiodothyronine |
| 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 | CDP |
| CFR Regulation Number | 862.1710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-12 |
| Decision Date | 1998-01-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963938 | K974634 | 000 |
| 00630414961385 | K974634 | 000 |
| 00630414961361 | K974634 | 000 |