510(k) K903366

KETONE TEST B SANWA STANDARD by Ihara Medics U.S., Inc. — Product Code JIN

K903366 is an FDA 510(k) premarket notification submitted by Ihara Medics U.S., Inc. for the device "KETONE TEST B SANWA STANDARD". The FDA issued a decision of Substantially Equivalent on November 20, 1990. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. Ihara Medics U.S., Inc. has at least 4 other 510(k) clearances on record.