510(k) K082661

BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A by Princeton BioMeditech Corp. — Product Code GTY

K082661 is an FDA 510(k) premarket notification submitted by Princeton BioMeditech Corp. for the device "BIOSTREP A, BIOSIGN STREP A, STATUSFIRST STREP A". The FDA issued a decision of Substantially Equivalent on October 6, 2008. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Princeton BioMeditech Corp. has at least 10 other 510(k) clearances on record.