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510(k) K875248

BIOSCAN URINE DIAGNOSTIC REAGENT STRIPS by Bioscan Instruments, Inc. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1988
Date Received
December 22, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)
Device Class
Class I
Regulation Number
862.1510
Review Panel
CH
Submission Type

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