K921183 is an FDA 510(k) clearance for the DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT. This device is classified as a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBM).
Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on June 19, 1992, 102 days after receiving the submission on March 9, 1992.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5090.
| 510(k) Number | K921183 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 09, 1992 |
| Decision Date | June 19, 1992 |
| Days to Decision | 102 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5090 |