The following data is part of a premarket notification filed by Unchanged with the FDA for Kronus Optiquant Thyroglobulin Kit.
| Device ID | K991720 |
| 510k Number | K991720 |
| Device Name: | KRONUS OPTIQUANT THYROGLOBULIN KIT |
| Classification | System, Test, Thyroglobulin |
| Applicant | UNCHANGED 1000 CALLE AMANECER San Clemente, CA 92673 |
| Contact | A.p. Doerscchuk |
| Correspondent | A.p. Doerscchuk UNCHANGED 1000 CALLE AMANECER San Clemente, CA 92673 |
| Product Code | MSW |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-05-20 |
| Decision Date | 1999-08-09 |