The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Monitect Mdma Drug Screen Cassette Test, Model Mc22; Fastect Ii Mdma Drug Screen Dipstick Test, Model Mf22.
| Device ID | K040203 |
| 510k Number | K040203 |
| Device Name: | MONITECT MDMA DRUG SCREEN CASSETTE TEST, MODEL MC22; FASTECT II MDMA DRUG SCREEN DIPSTICK TEST, MODEL MF22 |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618 |
| Contact | Raphael Wong |
| Correspondent | Raphael Wong BRANAN MEDICAL CORP. 10015 MUIRLANDS RD., SUITE E Irvine, CA 92618 |
| Product Code | DKZ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816565020977 | K040203 | 000 |
| 00816555021069 | K040203 | 000 |
| 00816555020116 | K040203 | 000 |