K820945 is an FDA 510(k) clearance for the SERA FOR ANTINUCLEAR ANTIBODIES. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DHN).
Submitted by Centers For Disease Control and Prevention (Walker, US). The FDA issued a Cleared decision on October 26, 1982, 203 days after receiving the submission on April 6, 1982.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K820945 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 06, 1982 |
| Decision Date | October 26, 1982 |
| Days to Decision | 203 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |