The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Folate Assay.
| Device ID | K992365 |
| 510k Number | K992365 |
| Device Name: | AIA-PACK FOLATE ASSAY |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Contact | Judith E Loebel |
| Correspondent | Judith E Loebel TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-15 |
| Decision Date | 1999-08-10 |