The following data is part of a premarket notification filed by Diagnostic Products Corp. with the FDA for Immulite Estradiol.
| Device ID | K932926 |
| 510k Number | K932926 |
| Device Name: | IMMULITE ESTRADIOL |
| Classification | Radioimmunoassay, Estradiol |
| 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 | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-15 |
| Decision Date | 1994-01-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414953731 | K932926 | 000 |
| 00630414974095 | K932926 | 000 |
| 00630414953724 | K932926 | 000 |
| 00630414947914 | K932926 | 000 |
| 00630414947907 | K932926 | 000 |
| 00630414947891 | K932926 | 000 |