The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Ige Ii Assay.
| Device ID | K972697 |
| 510k Number | K972697 |
| Device Name: | AIA-PACK IGE II ASSAY |
| Classification | Ige, Antigen, Antiserum, Control |
| 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 | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-18 |
| Decision Date | 1997-10-03 |