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.
Device ID | K071030 |
510k Number | K071030 |
Device Name: | BIONEXIA HCG PREGNANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS, MODELS 08-HCGC AND 02-HCGC |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | APPLIED DNA TECHNOLOGIES, INC. 6310 NANCY RIDGE DRIVE SUITE 106 San Diego, CA 92121 |
Contact | Feng-yu Lee |
Correspondent | Feng-yu Lee APPLIED DNA TECHNOLOGIES, INC. 6310 NANCY RIDGE DRIVE SUITE 106 San Diego, CA 92121 |
Product Code | JHI |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-04-11 |
Decision Date | 2007-06-29 |
Summary: | summary |