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510(k) K842256

AS LATEX PLUS by Biokit USA, Inc. — Product Code GTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 19, 1984
Date Received
June 7, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

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