• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter

  • 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
Document NumberK926362
Test Name BAYER CORPORATION, GLUCOSTIX REAGENT STRIPS  
Manufacturer NameHERAEUS KULZER, INC.
Consumer Information Phone NumberNO PHONE NUMBER
Test TypeGlucose monitoring devices (FDA cleared/home use)
Effective Date11/10/1993
Device Classification Name glucose oxidase, glucose
510(k) Number K926362
Device Name GLUCOSTIX REAGENT STRIPS
Applicant
HERAEUS KULZER, INC.
P.O. BOX 2004
MISHAWAKA,  IN  46546 -2004
Applicant Contact ROSANNE M SAVOL
Correspondent
HERAEUS KULZER, INC.
P.O. BOX 2004
MISHAWAKA,  IN  46546 -2004
Correspondent Contact ROSANNE M SAVOL
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/21/1992
Decision Date 11/10/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-