K840221 is an FDA 510(k) clearance for the EXTRACTABLE NUCLEAR ANTIGEN ASSAY. This device is classified as a Extractable Antinuclear Antibody, Antigen And Control (Class II - Special Controls, product code LLL).
Submitted by Zeus Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 22, 1984, 124 days after receiving the submission on January 19, 1984.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K840221 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 19, 1984 |
| Decision Date | May 22, 1984 |
| Days to Decision | 124 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | LLL — Extractable Antinuclear Antibody, Antigen And Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |