510(k) K921958

ELISA TUBE TSH TEST by Bio Clinic Co. — Product Code JLW

K921958 is an FDA 510(k) premarket notification submitted by Bio Clinic Co. for the device "ELISA TUBE TSH TEST". The FDA issued a decision of Substantially Equivalent on July 2, 1992. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Bio Clinic Co. has at least 10 other 510(k) clearances on record.