The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Toxcup Drug Screen Cup.
| Device ID | K122633 |
| 510k Number | K122633 |
| Device Name: | TOXCUP DRUG SCREEN CUP |
| Classification | Enzyme Immunoassay, Cannabinoids |
| 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 | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2013-02-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040090302 | K122633 | 000 |
| 00816565020663 | K122633 | 000 |
| 00816565020656 | K122633 | 000 |
| 00816565020649 | K122633 | 000 |
| 00816565020632 | K122633 | 000 |
| 00816555021526 | K122633 | 000 |
| 00816555020673 | K122633 | 000 |
| 00816555020505 | K122633 | 000 |
| 00816555020499 | K122633 | 000 |
| 00816555020482 | K122633 | 000 |
| 00816555020475 | K122633 | 000 |
| 00816565020670 | K122633 | 000 |
| 00816565020687 | K122633 | 000 |
| 00816565021332 | K122633 | 000 |
| 10304040090289 | K122633 | 000 |
| 00868754000208 | K122633 | 000 |
| 00858886006322 | K122633 | 000 |
| 00858886006285 | K122633 | 000 |
| 00817405020386 | K122633 | 000 |
| 00817405020379 | K122633 | 000 |
| 00817405020027 | K122633 | 000 |
| 00817405020010 | K122633 | 000 |
| 00816610020082 | K122633 | 000 |
| 00816610020068 | K122633 | 000 |
| 00643281710055 | K122633 | 000 |