AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE

Radioimmunoassay, Progesterone

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Progesterone Radioimmunoassay Kit Code.

Pre-market Notification Details

Device IDK845026
510k NumberK845026
Device Name:AMERLEX-M PROGESTERONE RADIOIMMUNOASSAY KIT CODE
ClassificationRadioimmunoassay, Progesterone
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactPhilip M Fantasia
CorrespondentPhilip M Fantasia
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-27
Decision Date1985-02-01

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