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510(k) K870500

MAJOR QUALITY GLUCOSE AND KETONES URINE TEST by American Diagnostic Corp. — Product Code JIL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 6, 1987
Date Received
February 4, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device Class
Class II
Regulation Number
862.1340
Review Panel
CH
Submission Type

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