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510(k) K852611

TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE by Miles Laboratories, Inc. — Product Code CDM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
June 19, 1985
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

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