510(k) K011525

SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM) by Biosafe Laboratories, Inc. — Product Code JLW

K011525 is an FDA 510(k) premarket notification submitted by Biosafe Laboratories, Inc. for the device "SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)". The FDA issued a decision of Substantially Equivalent on July 16, 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.