The following data is part of a premarket notification filed by Branan Medical Corporation with the FDA for Fastect Ii Bup Drug Screen Dipstick And Quicktox Bup Drug Screen Dipcard.
| Device ID | K082508 |
| 510k Number | K082508 |
| Device Name: | FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BRANAN MEDICAL CORPORATION 140 TECHNOLOGY DRIVE SUITE 400 Irvine, CA 92618 |
| Contact | Raphael Wong |
| Correspondent | Raphael Wong BRANAN MEDICAL CORPORATION 140 TECHNOLOGY DRIVE SUITE 400 Irvine, CA 92618 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-29 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816565020991 | K082508 | 000 |
| 00816555021083 | K082508 | 000 |