Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Enzyme Immunoassay, Cannabinoids
510(k) Number K132096
Device Name RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC CONTROL SET, COLLECTOR
Applicant
Biophor Diagnostics, Inc.
1201 Douglas Ave.
Redwood City,  CA  94063
Applicant Contact Nathaniel G Butlin
Correspondent
Biophor Diagnostics, Inc.
1201 Douglas Ave.
Redwood City,  CA  94063
Correspondent Contact Nathaniel G Butlin
Regulation Number862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIF   DKB  
Date Received07/08/2013
Decision Date 10/18/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-