• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name enzymatic, carbon-dioxide
510(k) Number K932267
Device Name ENZYMATIC CO2 REAGENT, MODIFICATION
Original Applicant
INTERSECT SYSTEMS, INC.
1152 3rd ave., suite d/e
p.o. box 2219
longview,  WA  98632
Original Contact taras tatarko
Regulation Number862.1160
Classification Product Code
KHS  
Date Received04/14/1993
Decision Date 09/24/1993
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-