The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for 125i Estradiol Direct Radioimmunoassay.
| Device ID | K853208 |
| 510k Number | K853208 |
| Device Name: | 125I ESTRADIOL DIRECT RADIOIMMUNOASSAY |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | TRAVENOL LABORATORIES, S.A. 600 MEMORIAL DR. Cambridge, MA 02139 |
| Contact | Rosa L Ditucci |
| Correspondent | Rosa L Ditucci TRAVENOL LABORATORIES, S.A. 600 MEMORIAL DR. Cambridge, MA 02139 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-31 |
| Decision Date | 1985-08-19 |