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 Ph Rate Measurement, Carbon-Dioxide
510(k) Number K900420
Device Name BICARBONATE REAGENTS PRODUCT #7713 & #7714
Applicant
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Applicant Contact C. K OWENS
Correspondent
American Research Products Co.
30175 Solon Industrial Pkwy.
P.O. Box 39098
Solon,  OH  44139
Correspondent Contact C. K OWENS
Regulation Number862.1160
Classification Product Code
JFL  
Date Received01/30/1990
Decision Date 03/01/1990
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
-
-