The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Fastect Ii Ppx Drug Screen Dipstick, Fastect Ii Drug Screen Dipstick, Quicktox Drug Screen Dipcard.
| Device ID | K122752 |
| 510k Number | K122752 |
| Device Name: | FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD |
| Classification | Enzyme Immunoassay, Propoxyphene |
| Applicant | BRANAN MEDICAL CORP. 140 Technology Dr Ste 400 Irvine, CA 92618 |
| Contact | Olivia Chan |
| Correspondent | Olivia Chan BRANAN MEDICAL CORP. 140 Technology Dr Ste 400 Irvine, CA 92618 |
| Product Code | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-07 |
| Decision Date | 2013-01-30 |
| Summary: | summary |