VIDAS PROESTERONE (PRG) (30 409)

Radioimmunoassay, Progesterone

BIOMERIEUX, INC.

The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Vidas Proesterone (prg) (30 409).

Pre-market Notification Details

Device IDK965084
510k NumberK965084
Device Name:VIDAS PROESTERONE (PRG) (30 409)
ClassificationRadioimmunoassay, Progesterone
Applicant BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland,  MA  02370
ContactTerry Mcgovern
CorrespondentTerry Mcgovern
BIOMERIEUX, INC. 1022 HINGHAM ST. Rockland,  MA  02370
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-12-19
Decision Date1997-01-09
Summary:summary

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