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 Analyzer, Chemistry, Centrifugal, For Clinical Use
510(k) Number K854055
Device Name I.C.L.S. COMPULYZER
Applicant
Integrated Computerized Laboratory Systems, Inc.
3959 Electric Rd., SW
Roanoke,  VA  24018
Applicant Contact STEVEN J HOLT
Correspondent
Integrated Computerized Laboratory Systems, Inc.
3959 Electric Rd., SW
Roanoke,  VA  24018
Correspondent Contact STEVEN J HOLT
Regulation Number862.2140
Classification Product Code
JJG  
Date Received10/03/1985
Decision Date 11/19/1985
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
-
-