AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)

Ferritin, Antigen, Antiserum, Control

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ferritin Assay (additional Protocol).

Pre-market Notification Details

Device IDK892362
510k NumberK892362
Device Name:AMERLITE FERRITIN ASSAY (ADDITIONAL PROTOCOL)
ClassificationFerritin, Antigen, Antiserum, Control
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 CodeDBF  
CFR Regulation Number866.5340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-06
Decision Date1989-05-09

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