K000336 is an FDA 510(k) clearance for the RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E. This device is classified as a Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) (Class II - Special Controls, product code NBO).
Submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on June 9, 2000, 127 days after receiving the submission on February 3, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K000336 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2000 |
| Decision Date | June 09, 2000 |
| Days to Decision | 127 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | NBO — Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |