The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Folate Assay.
| Device ID | K964349 |
| 510k Number | K964349 |
| Device Name: | AIA-PACK FOLATE ASSAY |
| Classification | Acid, Folic, Radioimmunoassay |
| Applicant | TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Contact | Lori Robinson |
| Correspondent | Lori Robinson TOSOH MEDICS, INC. 373 VINTAGE PARK DR. SUITE D Foster City, CA 94404 |
| Product Code | CGN |
| CFR Regulation Number | 862.1295 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-31 |
| Decision Date | 1996-11-27 |