K831358 is an FDA 510(k) clearance for the AUTOANTIBODY SCREEN TEST SYSTEM. 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 June 15, 1983, 50 days after receiving the submission on April 26, 1983.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5090.
| 510(k) Number | K831358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 26, 1983 |
| Decision Date | June 15, 1983 |
| Days to Decision | 50 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5090 |