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 K870827
Device Name INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT
Applicant
INTERSECT SYSTEMS, INC.
1606 E. KESSLER BLVD., #100
P.O. BOX 889
LONGVIEW,  WA  98632
Applicant Contact LESTER B GARRISON
Correspondent
INTERSECT SYSTEMS, INC.
1606 E. KESSLER BLVD., #100
P.O. BOX 889
LONGVIEW,  WA  98632
Correspondent Contact LESTER B GARRISON
Regulation Number862.1705
Classification Product Code
CDT  
Date Received03/03/1987
Decision Date 03/13/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-