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510(k) K901229

CHEM 1 CLINICAL ANALYZER (METHOD URINE CREATININE) by Technicon Instruments Corp. — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1990
Date Received
March 14, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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