K912291 is an FDA 510(k) clearance for the DISTAT ANTI-SCL-70 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 July 30, 1991, 68 days after receiving the submission on May 23, 1991.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K912291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 1991 |
| Decision Date | July 30, 1991 |
| Days to Decision | 68 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 |