K932876 is an FDA 510(k) clearance for the DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT. This device is classified as a Antinuclear Antibody, Antigen, Control (Class II - Special Controls, product code LKJ).
Submitted by Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on November 15, 1993, 154 days after receiving the submission on June 14, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K932876 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1993 |
| Decision Date | November 15, 1993 |
| Days to Decision | 154 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | LKJ — Antinuclear Antibody, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |