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 Olive Oil Emulsion (Turbidimetric), Lipase
510(k) Number K970124
Device Name LIPASE REAGENT SET (COLIPASE METHOD)
Applicant
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Applicant Contact ANDREW REAMS
Correspondent
Teco Diagnostics
4925 E. Hunter Ave.
Anaheim,  CA  92807
Correspondent Contact ANDREW REAMS
Regulation Number862.1465
Classification Product Code
CET  
Date Received01/14/1997
Decision Date 03/06/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-