Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls— 510(k) K142293
Substantially EquivalentBiophor Diagnostics, Inc.
FDA 510(k) clearance K142293 for Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls, Substantially Equivalent on 2015-09-18. Applicant: Biophor Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Biophor Diagnostics, Inc.
- Product code
- Code LAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.3610
- Advisory panel
- Clinical Toxicology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Redwood City, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.