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 Dialyzer Reprocessing System
510(k) Number K040660
Device Name STERICHEK GLUTARALDEHYDE REAGENT STRIPS
Applicant
Hach Company
23575 County Rd. 106
Elkhart,  IN  46514
Applicant Contact DAVID A MORRIS
Correspondent
Hach Company
23575 County Rd. 106
Elkhart,  IN  46514
Correspondent Contact DAVID A MORRIS
Regulation Number876.5820
Classification Product Code
LIF  
Date Received03/12/2004
Decision Date 11/15/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-