The following data is part of a premarket notification filed by Hybritech, Inc. with the FDA for Tandem - Eprl.
| Device ID | K843804 |
| 510k Number | K843804 |
| Device Name: | TANDEM - EPRL |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | HYBRITECH, INC. 11085 TORREYANA RD. San Diego, CA 92126 -9006 |
| Contact | John F Bruni |
| Correspondent | John F Bruni HYBRITECH, INC. 11085 TORREYANA RD. San Diego, CA 92126 -9006 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-27 |
| Decision Date | 1984-11-13 |