510(k) K895396

CYBERFLUOR FIAGEN TSH by Cyberfluor, Inc. — Product Code JLW

K895396 is an FDA 510(k) premarket notification submitted by Cyberfluor, Inc. for the device "CYBERFLUOR FIAGEN TSH". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Cyberfluor, Inc. has at least 10 other 510(k) clearances on record.