510(k) K890148

ATS TB RAPID STAIN SET PRODUCT #034-45 by Alpha-Tec Systems, Inc. — Product Code ICL

K890148 is an FDA 510(k) premarket notification submitted by Alpha-Tec Systems, Inc. for the device "ATS TB RAPID STAIN SET PRODUCT #034-45". The FDA issued a decision of Substantially Equivalent on January 24, 1989. The device falls under product code ICL (Carbol Fuchsin), a Class I device regulated under 21 CFR 864.1850. Alpha-Tec Systems, Inc. has at least 10 other 510(k) clearances on record.