510(k) K891098

ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) by Immco Diagnostics, Inc. — Product Code DBL

K891098 is an FDA 510(k) premarket notification submitted by Immco Diagnostics, Inc. for the device "ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS)". The FDA issued a decision of Substantially Equivalent on March 22, 1989. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Immco Diagnostics, Inc. has at least 10 other 510(k) clearances on record.