K955431 is an FDA 510(k) clearance for the RIT LIVER, KIDNEY, STOMACH IFA KIT. This device is classified as a Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (Class II - Special Controls, product code DBL).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on April 23, 1996, 147 days after receiving the submission on November 28, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K955431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 28, 1995 |
| Decision Date | April 23, 1996 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DBL — Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |