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510(k) K830091

LITH A TEST TM by Lenal Creative Approaches, Inc. — Product Code CEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 15, 1983
Date Received
January 11, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

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