BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC

Visual, Pregnancy Hcg, Prescription Use

APPLIED DNA TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Applied Dna Technologies, Inc. with the FDA for Bionexia Hcg Pregnancy Serum/urine Cassette And Dipstick Tests, Models 08-hcgc And 02-hcgc.

Pre-market Notification Details

Device IDK071030
510k NumberK071030
Device Name:BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant APPLIED DNA TECHNOLOGIES, INC. 6310 NANCY RIDGE DRIVE SUITE 106 San Diego,  CA  92121
ContactFeng-yu Lee
CorrespondentFeng-yu Lee
APPLIED DNA TECHNOLOGIES, INC. 6310 NANCY RIDGE DRIVE SUITE 106 San Diego,  CA  92121
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-04-11
Decision Date2007-06-29
Summary:summary

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