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 Enzymatic, Carbon-Dioxide
510(k) Number K880794
Device Name RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL
Applicant
Trace America, Inc.
P.O. Box 45-1835
Miami,  FL  33245
Applicant Contact RAY LOPEZ
Correspondent
Trace America, Inc.
P.O. Box 45-1835
Miami,  FL  33245
Correspondent Contact RAY LOPEZ
Regulation Number862.1160
Classification Product Code
KHS  
Date Received02/26/1988
Decision Date 04/18/1988
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
-
-