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 Electrode, Ion Specific, Calcium
510(k) Number K984299
Device Name AVL OPTI CRITICAL CARE ANALYZER
Applicant
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Applicant Contact RANDY BYRD
Correspondent
Avl Scientific Corp.
33 Mansell Ct.
Roswell,  GA  30076
Correspondent Contact RANDY BYRD
Regulation Number862.1145
Classification Product Code
JFP  
Subsequent Product Codes
CGZ   CHL   GKR   GLY   JGS  
Date Received12/01/1998
Decision Date 12/11/1998
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
-
-