PROGESTERONE RADIOIMMUNOASSAY KIT

Radioimmunoassay, Progesterone

IMMUNOTECH CORP.

The following data is part of a premarket notification filed by Immunotech Corp. with the FDA for Progesterone Radioimmunoassay Kit.

Pre-market Notification Details

Device IDK931228
510k NumberK931228
Device Name:PROGESTERONE RADIOIMMUNOASSAY KIT
ClassificationRadioimmunoassay, Progesterone
Applicant IMMUNOTECH CORP. 130, AVENUE JEAN DE LATTRE DE TASSIGNY-BP 177, 13276 MARSEIL Cedex 9 (france),  FR
ContactPrince
CorrespondentPrince
IMMUNOTECH CORP. 130, AVENUE JEAN DE LATTRE DE TASSIGNY-BP 177, 13276 MARSEIL Cedex 9 (france),  FR
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-10
Decision Date1993-10-22

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