The following data is part of a premarket notification filed by Kronus with the FDA for Anti-thyroglobulin Test Kit.
| Device ID | K894203 |
| 510k Number | K894203 |
| Device Name: | ANTI-THYROGLOBULIN TEST 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 | 1989-06-19 |
| Decision Date | 1989-07-25 |