K760155 is an FDA 510(k) clearance for the TEST, (IVDP) MITOCHONDRIAL ANTIBODY. This device is classified as a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBM).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 20, 1976, 18 days after receiving the submission on July 2, 1976.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090.
| 510(k) Number | K760155 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1976 |
| Decision Date | July 20, 1976 |
| Days to Decision | 18 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5090 |