510(k) K010734
- Device
- BRANAN MEDICAL CORPERATION MONITECT TCA DRUG SCREEN TEST, MODEL MC21 AND MD21
- Applicant
- Branan Medical Corp.
- 510(k) number
- K010734
- Product code
- MLK
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-07-30
- Date received
- 2001-03-12
- Regulation
- 862.3910
- Classification name
- Thin Layer Chromatography, Tricyclic Antidepressant Drugs
- Medical specialty
- Clinical Toxicology
- Review panel
- Clinical Toxicology
- Device class
- 2
- Clearance type
- Traditional
- 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#
- 2029372
- 2020952
- 2060833
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MLK#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K022693 | INSTANT-VIEW TCA URINE TEST | Alfa Scientific Designs, Inc. | 2002-12-09 |