K830214 is an FDA 510(k) clearance for the AFT SYSTEM III. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN).
Submitted by Calbiochem-Behring Corp. (Walker, US). The FDA issued a Cleared decision on March 9, 1983, 44 days after receiving the submission on January 24, 1983.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K830214 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent — Traditional 510(k) (SESE) |
| Date Received | January 24, 1983 |
| Decision Date | March 09, 1983 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.5100 |