The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack E2 Assay.
| Device ID | K932084 |
| 510k Number | K932084 |
| Device Name: | AIA-PACK E2 ASSAY |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Contact | Judith E Loebel |
| Correspondent | Judith E Loebel TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-30 |
| Decision Date | 1993-11-09 |