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 Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K950326
Device Name KENLOR HUMAN SPINAL FLUID CONTROL
Applicant
Kenlor Industries, Inc.
1560 E. Edinger Ave.,
Suite A-1
Santa Ana,  CA  92705
Applicant Contact KAMALES SOM
Correspondent
Kenlor Industries, Inc.
1560 E. Edinger Ave.,
Suite A-1
Santa Ana,  CA  92705
Correspondent Contact KAMALES SOM
Regulation Number862.1660
Classification Product Code
JJY  
Date Received01/18/1995
Decision Date 03/20/1995
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
-
-