510(k) K971522

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II by Abbott Laboratories — Product Code GTZ

K971522 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II". The FDA issued a decision of Substantially Equivalent on March 3, 1998. The device falls under product code GTZ (Antisera, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Abbott Laboratories has at least 10 other 510(k) clearances on record.