510(k) K980819

BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS by Biocircuits Corp. — Product Code CEC

K980819 is an FDA 510(k) premarket notification submitted by Biocircuits Corp. for the device "BIOCIRCUITS IOS FREE THYROXINE (FT4) TEST CARTRIDGES BIOCIRCUITS IOS CONTROLS". The FDA issued a decision of Substantially Equivalent on April 3, 1998. The device falls under product code CEC (Radioimmunoassay, Free Thyroxine), a Class II device regulated under 21 CFR 862.1695. Biocircuits Corp. has at least 7 other 510(k) clearances on record.