The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia Nexia-automated Enzyme Immunoassay System.
| Device ID | K971103 |
| 510k Number | K971103 |
| Device Name: | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM |
| Classification | Fluorometer, For Clinical Use |
| 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 | KHO |
| CFR Regulation Number | 862.2560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-26 |
| Decision Date | 1997-06-27 |