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 Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K842474
Device Name GLUCOCHEK III
Applicant
Larken Industries, Inc.
8347 Melrose
Lenexa,  KS  66214
Applicant Contact KEN ANDERSON
Correspondent
Larken Industries, Inc.
8347 Melrose
Lenexa,  KS  66214
Correspondent Contact KEN ANDERSON
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received06/25/1984
Decision Date 02/12/1985
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
-
-