Atlas FDA

Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls

FDA 510(k) clearance K142293 · decided 2015-09-18

Clearance details

K-number
K142293
Device name
Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls
Applicant
Biophor Diagnostics, Inc.
Decision
Substantially Equivalent
Date received
2014-08-18
Decision date
2015-09-18
Days to decision
396 days
Clearance type
Traditional
Product code
LAF
Device class
2
Regulation number
862.3610
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Redwood City, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.