STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY

Radioimmunoassay, Progesterone

BAXTER DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Baxter Diagnostics, Inc. with the FDA for Stratus Progesterone Fluorometric Enzyme Immunoassay.

Pre-market Notification Details

Device IDK950570
510k NumberK950570
Device Name:STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY
ClassificationRadioimmunoassay, Progesterone
Applicant BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami,  FL  33152
ContactRichard D Bliss Jr.
CorrespondentRichard D Bliss Jr.
BAXTER DIAGNOSTICS, INC. P.O. BOX 520672 Miami,  FL  33152
Product CodeJLS  
CFR Regulation Number862.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-02-03
Decision Date1995-04-11

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