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510(k) K880584

URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C by Mach Diag. C/O Wichita State University — Product Code CDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 1988
Date Received
February 10, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Device Class
Class I
Regulation Number
862.1785
Review Panel
CH
Submission Type

Other clearances by Mach Diag. C/O Wichita State University

  • K880585 — DEXPAD, BLOOD GLUCOSE STRIP (April 18, 1988)

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  • K831623 — DIA STRIPS SYSTEM (July 28, 1983)
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