The following data is part of a premarket notification filed by Tosoh Medics, Inc. with the FDA for Aia-pack Troponin I Assay.
| Device ID | K984359 |
| 510k Number | K984359 |
| Device Name: | AIA-PACK TROPONIN I ASSAY |
| Classification | Immunoassay Method, Troponin Subunit |
| Applicant | TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Contact | Lori Robinson |
| Correspondent | Lori Robinson TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 San Francisco, CA 94080 |
| Product Code | MMI |
| CFR Regulation Number | 862.1215 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-07 |
| Decision Date | 1998-12-23 |