The following data is part of a premarket notification filed by Trace Scientific Ltd. with the FDA for Enzymatic Mitochondrial Antibody (m2) Reagent.
| Device ID | K982121 |
| 510k Number | K982121 |
| Device Name: | ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT |
| Classification | Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Contact | David Johnston |
| Correspondent | David Johnston TRACE SCIENTIFIC LTD. 7260 NORTH WEST 58TH ST. Miami, FL 33166 |
| Product Code | DBM |
| CFR Regulation Number | 866.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-16 |
| Decision Date | 1998-09-17 |