DIRIA-PROGK IMMUNOASSAY

Radioimmunoassay, Progesterone

SORIN BIOMEDICA, FIAT, USA, INC.

The following data is part of a premarket notification filed by Sorin Biomedica, Fiat, Usa, Inc. with the FDA for Diria-progk Immunoassay.

Pre-market Notification Details

Device IDK832694
510k NumberK832694
Device Name:DIRIA-PROGK IMMUNOASSAY
ClassificationRadioimmunoassay, Progesterone
Applicant SORIN BIOMEDICA, FIAT, USA, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-10
Decision Date1984-01-11

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