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510(k) K990873

DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USE by Ameritek, Inc. — Product Code JMT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1999
Date Received
March 16, 1999
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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