510(k) K980574

AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0 by Alfa Biotech (Uk) , Ltd. — Product Code JLW

K980574 is an FDA 510(k) premarket notification submitted by Alfa Biotech (Uk) , Ltd. for the device "AURAFLEX TSH-3 200 TEST PACK MODEL NUMBER 80600, AURAFLEX TSH-3 CALIBRATOR PACK MODEL NUMBER NUMBER 80601 AURAFLEX DIL0". The FDA issued a decision of Substantially Equivalent on March 24, 1998. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Alfa Biotech (Uk) , Ltd. has at least 2 other 510(k) clearances on record.