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 Acid, Lactic, Enzymatic Method
510(k) Number K130113
Device Name PICCOLO LACTATE TEST SYSTEM
Applicant
Abaxis, Inc.
3240 Whipple Rd.
Union City,  CA  94587
Applicant Contact Dennis M Bleile
Correspondent
Abaxis, Inc.
3240 Whipple Rd.
Union City,  CA  94587
Correspondent Contact Dennis M Bleile
Regulation Number862.1450
Classification Product Code
KHP  
Date Received01/16/2013
Decision Date 03/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-