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 Tubes, Vials, Systems, Serum Separators, Blood Collection
510(k) Number K962158
Device Name PICO MODELS 30, 50, 70
Applicant
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145 -1598
Applicant Contact DONALD L BAKER
Correspondent
Radiometer America, Inc.
810 Sharon Dr.
Westlake,  OH  44145 -1598
Correspondent Contact DONALD L BAKER
Regulation Number862.1675
Classification Product Code
JKA  
Date Received06/04/1996
Decision Date 10/29/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-