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 Lead, Atomic Absorption
510(k) Number K936060
Device Name ATOMSPEC GF BLOOD LEAD WORKSTATION
Applicant
Thermo Jarrell Ash Corp.Div.Thermo Inst.
8e Forge Pkwy.
Franklin,  MA  02038
Applicant Contact ZACK MOSELEY
Correspondent
Thermo Jarrell Ash Corp.Div.Thermo Inst.
8e Forge Pkwy.
Franklin,  MA  02038
Correspondent Contact ZACK MOSELEY
Regulation Number862.3550
Classification Product Code
DOF  
Date Received12/20/1993
Decision Date 09/06/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-