AMERSHAM TSH CONTROL SERA

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 Amersham Tsh Control Sera.

Pre-market Notification Details

Device IDK902760
510k NumberK902760
Device Name:AMERSHAM TSH CONTROL SERA
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactKathryn B Patterson
CorrespondentKathryn B Patterson
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 Received1990-06-25
Decision Date1990-07-27

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