The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Myoglobin Assay.
| Device ID | K981012 |
| 510k Number | K981012 |
| Device Name: | AIA-PACK MYOGLOBIN ASSAY |
| Classification | Myoglobin, 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 | DDR |
| CFR Regulation Number | 866.5680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-18 |
| Decision Date | 1998-05-28 |