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 Urinalysis Controls (Assayed And Unassayed)
510(k) Number K890577
Device Name KENLOR LIQUID URINE CONTROL
Applicant
Kenlor Industries, Inc.
8130 Mcfadden Ave., Suite 105
Westminster,  CA  92683
Applicant Contact SOM, PH.D.
Correspondent
Kenlor Industries, Inc.
8130 Mcfadden Ave., Suite 105
Westminster,  CA  92683
Correspondent Contact SOM, PH.D.
Regulation Number862.1660
Classification Product Code
JJW  
Date Received02/06/1989
Decision Date 03/09/1989
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
-
-