510(k) K901123

CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN by Technicon Instruments Corp. — Product Code CDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1990
Date Received
March 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease And Glutamic Dehydrogenase, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type