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 Chromatographic/Fluorometric Method, Catecholamines
510(k) Number K952919
Device Name URINARY METANEPHRINE KIT
Applicant
Bioanalytical Systems, Inc.
2701 Kent Ave.
West Lafayette,  IN  47906
Applicant Contact STEPHEN GEARY
Correspondent
Bioanalytical Systems, Inc.
2701 Kent Ave.
West Lafayette,  IN  47906
Correspondent Contact STEPHEN GEARY
Regulation Number862.1165
Classification Product Code
CHQ  
Date Received06/26/1995
Decision Date 09/06/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-