AMERLITE FREE THYROID CONTROL SERA LAN.4002

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 Amerlite Free Thyroid Control Sera Lan.4002.

Pre-market Notification Details

Device IDK883124
510k NumberK883124
Device Name:AMERLITE FREE THYROID CONTROL SERA LAN.4002
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactFrank Lyman
CorrespondentFrank Lyman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-26
Decision Date1988-09-30

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