DELFIA NEONATAL 17A-OH-PROGESTERONE KIT

Radioimmunoassay, 17-hydroxyprogesterone

WALLAC OY

The following data is part of a premarket notification filed by Wallac Oy with the FDA for Delfia Neonatal 17a-oh-progesterone Kit.

Pre-market Notification Details

Device IDK042424
510k NumberK042424
Device Name:DELFIA NEONATAL 17A-OH-PROGESTERONE KIT
ClassificationRadioimmunoassay, 17-hydroxyprogesterone
Applicant WALLAC OY MUSTIONKATU 6 Turku,  FI 20750
ContactGunnel Laaksonen
CorrespondentGunnel Laaksonen
WALLAC OY MUSTIONKATU 6 Turku,  FI 20750
Product CodeJLX  
CFR Regulation Number862.1395 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-08
Decision Date2004-09-30
Summary:summary

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