510(k) K771716

CYMET-PLUS by J.T. Baker Chemical Co. — Product Code GKK

K771716 is an FDA 510(k) premarket notification submitted by J.T. Baker Chemical Co. for the device "CYMET-PLUS". The FDA issued a decision of Substantially Equivalent on September 20, 1977. The device falls under product code GKK (Cyanomethemoglobin), a Class II device regulated under 21 CFR 864.7500. J.T. Baker Chemical Co. has at least 10 other 510(k) clearances on record.