510(k) K071030

BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC by Applied Dna Technologies, Inc. — Product Code JHI

K071030 is an FDA 510(k) premarket notification submitted by Applied Dna Technologies, Inc. for the device "BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC". 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.