K930987 is an FDA 510(k) clearance for the CRITHIDIA LUCILLIAE DS DNA KIT (DIAGNOSTIC USE). This device is classified as a Anti-dna Indirect Immunofluorescent Solid Phase (Class II - Special Controls, product code KTL).
Submitted by The Binding Site, Ltd. (Los Angeles, US). The FDA issued a Cleared decision on August 10, 1993, 166 days after receiving the submission on February 25, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.
| 510(k) Number | K930987 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1993 |
| Decision Date | August 10, 1993 |
| Days to Decision | 166 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | KTL — Anti-dna Indirect Immunofluorescent Solid Phase |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5100 |