510(k) K983185

BOEHRINGER MANNHEIM TINA-QUANT IGE TEST by Boehringer Mannheim Corp. — Product Code DGC

K983185 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "BOEHRINGER MANNHEIM TINA-QUANT IGE TEST". The FDA issued a decision of Substantially Equivalent on November 12, 1998. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.