RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Radioassay Controls 31 & 32, Anti-dsdna Control.

Pre-market Notification Details

Device IDK894329
510k NumberK894329
Device Name:RADIOASSAY CONTROLS 31 & 32, ANTI-DSDNA CONTROL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactFrank J Lyman
CorrespondentFrank J Lyman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-14
Decision Date1989-09-05

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