510(k) K933934

GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A by Sigma Diagnostics, Inc. — Product Code JBF

K933934 is an FDA 510(k) premarket notification submitted by Sigma Diagnostics, Inc. for the device "GLUCOSE-6-PHOSPHATE DEHYDROGENASE DEFICIENCY SCREENING TEST KIT NO. 202-A". The FDA issued a decision of Substantially Equivalent on June 29, 1995. The device falls under product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening), a Class II device regulated under 21 CFR 864.7360. Sigma Diagnostics, Inc. has at least 10 other 510(k) clearances on record.