510(k) K911849

IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST by General Biometrics, Inc. — Product Code LKO

K911849 is an FDA 510(k) premarket notification submitted by General Biometrics, Inc. for the device "IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on May 7, 1991. The device falls under product code LKO (Anti-Rnp Antibody, Antigen And Control), a Class II device regulated under 21 CFR 866.5100. General Biometrics, Inc. has at least 10 other 510(k) clearances on record.