The following data is part of a premarket notification filed by Immuno Concepts, Inc. with the FDA for Colorzyme Ndna Test System.
| Device ID | K843225 |
| 510k Number | K843225 |
| Device Name: | COLORZYME NDNA TEST SYSTEM |
| Classification | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control |
| Applicant | IMMUNO CONCEPTS, INC. 9779 I BUSINESS PARK DRIVE Sacramento , CA 95827 - |
| Contact | Don W Valencia |
| Correspondent | Don W Valencia IMMUNO CONCEPTS, INC. 9779 I BUSINESS PARK DRIVE Sacramento , CA 95827 - |
| Product Code | DHN |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-16 |
| Decision Date | 1984-11-01 |