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 Volumetric/Manometric, Carbon-Dioxide
510(k) Number K864313
Device Name CO2 REAGENT SET
Applicant
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Applicant Contact BARBARA H SNEADE
Correspondent
Hf Scientific, Inc.
3052 Metro Pkwy. SE
Ft. Myers,  FL  33916
Correspondent Contact BARBARA H SNEADE
Regulation Number862.1160
Classification Product Code
CIE  
Date Received11/03/1986
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
Predetermined Change
Control Plan Authorized		 No
-
-