510(k) K070921

BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG by Applied Dna Technologies, Inc. — Product Code JHI

K070921 is an FDA 510(k) premarket notification submitted by Applied Dna Technologies, Inc. for the device "BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG". The FDA issued a decision of Substantially Equivalent on June 29, 2007. The device falls under product code JHI (Visual, Pregnancy Hcg, Prescription Use), a Class II device regulated under 21 CFR 862.1155. Applied Dna Technologies, Inc. has at least 3 other 510(k) clearances on record.