The following data is part of a premarket notification filed by Kronus Market Development Associates, Inc. with the FDA for Kronus Tsh Receptor Autoantibody (trab) Elisa Assay Kit.
Device ID | K080159 |
510k Number | K080159 |
Device Name: | KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT |
Classification | System, Test, Thyroid Autoantibody |
Applicant | KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
Contact | Heather Viele |
Correspondent | Heather Viele KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. 12554 WEST BRIDGER ST. SUITE 108 Boise, ID 83713 |
Product Code | JZO |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2008-01-23 |
Decision Date | 2008-05-22 |