510(k) K192931

V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control by Helena Laboratories, Corp. — Product Code GKA

K192931 is an FDA 510(k) premarket notification submitted by Helena Laboratories, Corp. for the device "V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo Control". The FDA issued a decision of Substantially Equivalent on April 19, 2022. The device falls under product code GKA (Abnormal Hemoglobin Quantitation), a Class II device regulated under 21 CFR 864.7415. Helena Laboratories, Corp. has at least 10 other 510(k) clearances on record.