THYROID CONTROL SERA CODE QAS.101

Multi-analyte Controls, All Kinds (assayed)

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Thyroid Control Sera Code Qas.101.

Pre-market Notification Details

Device IDK790840
510k NumberK790840
Device Name:THYROID CONTROL SERA CODE QAS.101
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant AMERSHAM CORP. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-05-02
Decision Date1979-06-28

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