The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Monitect Multiple Drug Screen Tests, Model Bc12,bc14,tc10,pc11, And Pc12.
| Device ID | K004034 |
| 510k Number | K004034 |
| Device Name: | MONITECT MULTIPLE DRUG SCREEN TESTS, MODEL BC12,BC14,TC10,PC11, AND PC12 |
| 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 |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJC |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DOE |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-28 |
| Decision Date | 2001-03-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816555021397 | K004034 | 000 |
| 00816555021380 | K004034 | 000 |
| 00816555021373 | K004034 | 000 |
| 00816555021335 | K004034 | 000 |
| 00816555021304 | K004034 | 000 |
| 00816555021298 | K004034 | 000 |
| 00816555021281 | K004034 | 000 |
| 00816555020130 | K004034 | 000 |
| 00817815021003 | K004034 | 000 |