K842707 is an FDA 510(k) clearance for the ADP NDNA IFA TEST. This device is classified as a Anti-dna Indirect Immunofluorescent Solid Phase (Class II - Special Controls, product code KTL).
Submitted by Apple Diagnostic Products (Mchenry, US). The FDA issued a Cleared decision on August 21, 1984, 40 days after receiving the submission on July 12, 1984.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K842707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 1984 |
| Decision Date | August 21, 1984 |
| Days to Decision | 40 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | KTL — Anti-dna Indirect Immunofluorescent Solid Phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |