The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Prolactin.
| Device ID | K925846 |
| 510k Number | K925846 |
| Device Name: | IMMULITE PROLACTIN |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Contact | Kenneth B Asarch |
| Correspondent | Kenneth B Asarch DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. Los Angeles, CA 90045 -5597 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-18 |
| Decision Date | 1993-03-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414954189 | K925846 | 000 |
| 00630414964539 | K925846 | 000 |
| 00630414961941 | K925846 | 000 |
| 00630414961934 | K925846 | 000 |
| 00630414954172 | K925846 | 000 |
| 00630414167503 | K925846 | 000 |
| 00630414167497 | K925846 | 000 |