ANTI-DNASE B REAGENT SYSTEM

Antideoxyribonuclease, Streptococcus Spp.

CALBIOCHEM-BEHRING CORP.

The following data is part of a premarket notification filed by Calbiochem-behring Corp. with the FDA for Anti-dnase B Reagent System.

Pre-market Notification Details

Device IDK790997
510k NumberK790997
Device Name:ANTI-DNASE B REAGENT SYSTEM
ClassificationAntideoxyribonuclease, Streptococcus Spp.
Applicant CALBIOCHEM-BEHRING CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGTR  
CFR Regulation Number866.3720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-05-29
Decision Date1979-07-24

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