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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemodialysis, Access Recirculation Monitoring
510(k) Number K953875
Device Name CRIT-LINE HEMATOCRIT ALERT (MODIFICATION)
Applicant
In-Line Diagnostics Corp.
4646 S. 1500 W.,Suite 160
Riverdale,  UT  84405
Applicant Contact JAMES M CONIS
Correspondent
In-Line Diagnostics Corp.
4646 S. 1500 W.,Suite 160
Riverdale,  UT  84405
Correspondent Contact JAMES M CONIS
Regulation Number876.5820
Classification Product Code
MQS  
Date Received06/28/1995
Decision Date 07/23/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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