The following data is part of a premarket notification filed by Cronus with the FDA for 125-i Tsh Receptor Antibody Kit.
| Device ID | K863006 |
| 510k Number | K863006 |
| Device Name: | 125-I TSH RECEPTOR ANTIBODY KIT |
| Classification | System, Test, Thyroid Autoantibody |
| 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 | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-08 |
| Decision Date | 1986-09-08 |