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510(k) K790997

ANTI-DNASE B REAGENT SYSTEM by Calbiochem-Behring Corp. — Product Code GTR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1979
Date Received
May 29, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antideoxyribonuclease, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
Submission Type

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