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 Flame Photometry, Lithium
510(k) Number K031579
Device Name INSTAREAD LITHIUM SYSTEM
Applicant
Akers Laboratories, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Applicant Contact Erika B Ammirati
Correspondent
Akers Laboratories, Inc.
201 Grove Rd.
Thorofare,  NJ  08086
Correspondent Contact Erika B Ammirati
Regulation Number862.3560
Classification Product Code
JIH  
Date Received05/20/2003
Decision Date 12/19/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-