The following data is part of a premarket notification filed by Applied Dna Technologies, Inc. with the FDA for Bionexia Hcg Pregnancy Cassette And Dipstick Tests, Model 08-hcg And 02-hcg.
| Device ID | K070921 |
| 510k Number | K070921 |
| Device Name: | BIONEXIA HCG PREGNANCY CASSETTE AND DIPSTICK TESTS, MODEL 08-HCG AND 02-HCG |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | APPLIED DNA TECHNOLOGIES, INC. 26251 VERONA PLACE Mission Viejo, CA 92692 |
| Contact | Feng-yu Lee |
| Correspondent | Feng-yu Lee APPLIED DNA TECHNOLOGIES, INC. 26251 VERONA PLACE Mission Viejo, CA 92692 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-06-29 |
| Summary: | summary |