510(k) K883177

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER by Texas Intl. Laboratories, Inc. — Product Code GKZ

K883177 is an FDA 510(k) premarket notification submitted by Texas Intl. Laboratories, Inc. for the device "H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER". The FDA issued a decision of Substantially Equivalent on November 30, 1988. The device falls under product code GKZ (Counter, Differential Cell), a Class II device regulated under 21 CFR 864.5220. Texas Intl. Laboratories, Inc. has at least 9 other 510(k) clearances on record.