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510(k) K830979

HELENA BIOSTRIP PH by Helena Laboratories — Product Code CEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 5, 1983
Date Received
March 29, 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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