510(k) K003752

BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH) by Biosafe Laboratories, Inc. — Product Code JLW

K003752 is an FDA 510(k) premarket notification submitted by Biosafe Laboratories, Inc. for the device "BIOSAFE CAPILLARY BLOOD TRANSPORT SYSTEM FOR TESTING THYROID STIMULATING HORMONE (TSH)". The FDA issued a decision of Substantially Equivalent on March 23, 2001. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Biosafe Laboratories, Inc. has at least 5 other 510(k) clearances on record.