The following data is part of a premarket notification filed by Cronus with the FDA for I-125 Anti-microsomal Antibody Irma Test Kit.
| Device ID | K871194 |
| 510k Number | K871194 |
| Device Name: | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT |
| Classification | Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control |
| Applicant | CRONUS P.O. BOX 1827 Carlsbad, CA 92008 |
| Contact | Bob Cowden |
| Correspondent | Bob Cowden CRONUS P.O. BOX 1827 Carlsbad, CA 92008 |
| Product Code | DBL |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-24 |
| Decision Date | 1987-04-20 |