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510(k) K800642

RAPI/TEX ASO STANDARD SERUM by Calbiochem-Behring Corp. — Product Code GTQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1980
Date Received
March 24, 1980
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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