510(k) K992658

OSOM ULTRA STREP A TEST, MODEL 147 by Wyntek Diagnostics, Inc. — Product Code GTY

K992658 is an FDA 510(k) premarket notification submitted by Wyntek Diagnostics, Inc. for the device "OSOM ULTRA STREP A TEST, MODEL 147". The FDA issued a decision of Substantially Equivalent on January 18, 2000. The device falls under product code GTY (Antigens, All Groups, Streptococcus Spp.), a Class I device regulated under 21 CFR 866.3740. Wyntek Diagnostics, Inc. has at least 10 other 510(k) clearances on record.