ORATECT ORAL FLUID DRUG SCREEN DEVICES— 510(k) K103227
Substantially EquivalentBranan Medical Corporation
FDA 510(k) clearance K103227 for ORATECT ORAL FLUID DRUG SCREEN DEVICES, Substantially Equivalent on 2012-04-11. Applicant: Branan Medical Corporation. Device class: 2.
Clearance details
- Applicant
- Branan Medical Corporation
- Product code
- Code DIO
- Device class
- Class 2
- Regulation
- 21 CFR 862.3250
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.