510(k) K902237

MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT by Medica Corp. — Product Code DBL

K902237 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT". The FDA issued a decision of Substantially Equivalent on July 9, 1990. The device falls under product code DBL (Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control), a Class II device regulated under 21 CFR 866.5660. Medica Corp. has at least 10 other 510(k) clearances on record.