FDA 510(k) Applications Submitted by Nathaniel G Butlin

FDA 510(k) Number Submission Date Device Name Applicant
K141748 06/30/2014 RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL FLUID AMPHETAMINE CALIBRATOR SET, RAPIDFRET ORAL FLUID AMPHETAMINE CONTROL SET BIOPHOR DIAGNOSTICS, INC.
K132096 07/08/2013 RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR BIOPHOR DIAGNOSTICS, INC.
K122703 09/04/2012 RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP CONTROL SET AND RAPIDEASE ORAL FLUID COLLECTOR BIOPHOR DIAGNOSTICS, INC.
K133047 09/27/2013 RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU BIOPHOR DIAGNOSTICS, INC.
K133642 11/27/2013 RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID CALIBRATORS, CONTROLS, COLLECTOR; RAPIDFRET INTEGRATED WORK BIOPHOR DIAGNOSTICS, INC.
K142293 08/18/2014 Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine Controls BIOPHOR DIAGNOSTICS, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact