510(k) K942661

AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT by Sealite Sciences, Inc. — Product Code JLW

K942661 is an FDA 510(k) premarket notification submitted by Sealite Sciences, Inc. for the device "AQUALITE TSH BIOLUMINESCENT IMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on January 17, 1995. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Sealite Sciences, Inc. has at least 10 other 510(k) clearances on record.