510(k) K042379

ANEMIAPRO SELF-SCREENER by Biosafe Laboratories, Inc. — Product Code KHG

K042379 is an FDA 510(k) premarket notification submitted by Biosafe Laboratories, Inc. for the device "ANEMIAPRO SELF-SCREENER". The FDA issued a decision of Substantially Equivalent on December 15, 2004. The device falls under product code KHG (Whole Blood Hemoglobin Determination), a Class II device regulated under 21 CFR 864.7500. Biosafe Laboratories, Inc. has at least 5 other 510(k) clearances on record.