The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack(r) Prog Assay.
| Device ID | K933269 |
| 510k Number | K933269 |
| Device Name: | AIA-PACK(R) PROG ASSAY |
| Classification | Radioimmunoassay, Progesterone |
| 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 | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-06 |
| Decision Date | 1993-10-22 |