The following data is part of a premarket notification filed by Kronus with the FDA for Kronus Kalibre Thyroglobulin Antibody Eia Kit.
| Device ID | K915428 |
| 510k Number | K915428 |
| Device Name: | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | KRONUS P.O. BOX 1075 SUITE 312 Dana Point, CA 92629 |
| Contact | Doerschuk |
| Correspondent | Doerschuk KRONUS P.O. BOX 1075 SUITE 312 Dana Point, CA 92629 |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-02 |
| Decision Date | 1992-03-30 |