K822607 is an FDA 510(k) clearance for the ANTINUCLEAR ANTOBODY CELL SUBSTRATE. This device is classified as a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DHN).
Submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 17, 1982, 21 days after receiving the submission on August 27, 1982.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K822607 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 27, 1982 |
| Decision Date | September 17, 1982 |
| Days to Decision | 21 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 |