510(k) K901123

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

K901123 is an FDA 510(k) premarket notification submitted by Technicon Instruments Corp. for the device "CHEM 1 CLINICAL ANALYZER URINE UREA NITROGEN". The FDA issued a decision of Substantially Equivalent on May 10, 1990. The device falls under product code CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Technicon Instruments Corp. has at least 10 other 510(k) clearances on record.