K990916 is an FDA 510(k) clearance for the INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY. This device is classified as a Anti-dna Indirect Immunofluorescent Solid Phase (Class II - Special Controls, product code KTL).
Submitted by Stellar Bio Systems, Inc. (Columbia, US). The FDA issued a Cleared decision on April 21, 1999, 34 days after receiving the submission on March 18, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K990916 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1999 |
| Decision Date | April 21, 1999 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | KTL — Anti-dna Indirect Immunofluorescent Solid Phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |