510(k) K013124
- Device
- MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP
- Applicant
- Branan Medical Corp.
- 510(k) number
- K013124
- Product code
- DJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-11-07
- Date received
- 2001-09-19
- Regulation
- 862.3640
- Classification name
- Fluorometry, Morphine
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- RAPHAEL WONG
- Address
- 10015 Muirlands Rd., Suite E Irvine CA US 92618 92618
FDA Registration Numbers#
- 2031229
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA