510(k) K792562

IMMUNOSTAT TSH TEST by Meloy Laboratories, Inc. — Product Code JLW

K792562 is an FDA 510(k) premarket notification submitted by Meloy Laboratories, Inc. for the device "IMMUNOSTAT TSH TEST". The FDA issued a decision of Substantially Equivalent on January 16, 1980. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Meloy Laboratories, Inc. has at least 10 other 510(k) clearances on record.