DIGOXIN & PHENYTOIN CONTROL SERA

Drug Mixture Control Materials

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Digoxin & Phenytoin Control Sera.

Pre-market Notification Details

Device IDK803097
510k NumberK803097
Device Name:DIGOXIN & PHENYTOIN CONTROL SERA
ClassificationDrug Mixture Control Materials
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDIF  
CFR Regulation Number862.3280 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1980-12-08
Decision Date1980-12-22

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