510(k) K992791

BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO by Brahms Diagnostica, LLC — Product Code JZO

K992791 is an FDA 510(k) premarket notification submitted by Brahms Diagnostica, LLC for the device "BRAHMS DIAGNOSTICA DYNOTEST ANTI-TPO". The FDA issued a decision of Substantially Equivalent on November 12, 1999. The device falls under product code JZO (System, Test, Thyroid Autoantibody), a Class II device regulated under 21 CFR 866.5870. Brahms Diagnostica, LLC has at least 5 other 510(k) clearances on record.