The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Cort Assay.
| Device ID | K954591 |
| 510k Number | K954591 |
| Device Name: | AIA-PACK CORT ASSAY |
| Classification | Fluorometric, Cortisol |
| Applicant | TOSOH MEDICS, INC. 373 D VINTAGE PARK DR. Foster City, CA 94404 |
| Contact | Lori Robinson |
| Correspondent | Lori Robinson TOSOH MEDICS, INC. 373 D VINTAGE PARK DR. Foster City, CA 94404 |
| Product Code | JFT |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-10-02 |
| Decision Date | 1995-12-15 |