The following data is part of a premarket notification filed by Branan Medical Corp. with the FDA for Branan Medical Corporation Monitect Pcp Drug Screen Test, Model 160c And 160d.
| Device ID | K002272 |
| 510k Number | K002272 |
| Device Name: | BRANAN MEDICAL CORPORATION MONITECT PCP DRUG SCREEN TEST, MODEL 160C AND 160D |
| Classification | Enzyme Immunoassay, Phencyclidine |
| 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 | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-26 |
| Decision Date | 2000-11-22 |