The following data is part of a premarket notification filed by Rhigene, Inc. with the FDA for Rhigene Dsg-1 & Dsg-3 Elisa Test System, Model 7680 E.
| Device ID | K000336 |
| 510k Number | K000336 |
| Device Name: | RHIGENE DSG-1 & DSG-3 ELISA TEST SYSTEM, MODEL 7680 E |
| Classification | Autoantibodies, Skin (desmoglein 1 And Desmoglein 3) |
| Applicant | RHIGENE, INC. 455 STATE ST., SUITE 104 Des Plaines, IL 60068 |
| Contact | Dave Kolesar |
| Correspondent | Dave Kolesar RHIGENE, INC. 455 STATE ST., SUITE 104 Des Plaines, IL 60068 |
| Product Code | NBO |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-03 |
| Decision Date | 2000-06-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110RGM7593D0 | K000336 | 000 |