K811261 is an FDA 510(k) clearance for the ANTI-SKIN ANTIBODY TEST SYSTEM. This device is classified as a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBL).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on August 12, 1981, 98 days after receiving the submission on May 6, 1981.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K811261 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1981 |
| Decision Date | August 12, 1981 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |