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510(k) K830978

HELENA BIOSTRIP A by Helena Laboratories — Product Code JMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 1983
Date Received
March 29, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Device Class
Class I
Regulation Number
862.1095
Review Panel
CH
Submission Type

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