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 |