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 lipase hydrolysis/glycerol kinase enzyme, triglycerides
510(k) Number K993466
Device Name WAKO L-TYPE TRIGLYCERIDE TEST
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Applicant Contact TONYA MALLORY
Correspondent
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Correspondent Contact TONYA MALLORY
Regulation Number862.1705
Classification Product Code
CDT  
Date Received10/13/1999
Decision Date 11/09/1999
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
-
-