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 |