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 Instrument, Hematocrit, Automated
510(k) Number K983551
Device Name CRIT-SCAN II MONITOR
Applicant
In-Line Diagnostics Corp.
117 W. 200 S.
Farmington,  UT  84025
Applicant Contact MATTHEW L HAYNIE
Correspondent
In-Line Diagnostics Corp.
117 W. 200 S.
Farmington,  UT  84025
Correspondent Contact MATTHEW L HAYNIE
Regulation Number864.5600
Classification Product Code
GKF  
Date Received10/09/1998
Decision Date 05/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-