• 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 K790773
Device Name ENZYMATIC TRIGLYCERIDES-S.V.R.
Applicant
CALBIOCHEM-BEHRING CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CALBIOCHEM-BEHRING CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1705
Classification Product Code
CDT  
Date Received04/20/1979
Decision Date 06/15/1979
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-