OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT

Myoglobin, Antigen, Antiserum, Control

OLYMPUS DIAGNOSTICA GMBH

The following data is part of a premarket notification filed by Olympus Diagnostica Gmbh with the FDA for Olympus Myoglobin Immunoturbidmetric Reagent.

Pre-market Notification Details

Device IDK984145
510k NumberK984145
Device Name:OLYMPUS MYOGLOBIN IMMUNOTURBIDMETRIC REAGENT
ClassificationMyoglobin, Antigen, Antiserum, Control
Applicant OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747
ContactLaura Storms-tyler
CorrespondentLaura Storms-tyler
OLYMPUS DIAGNOSTICA GMBH TWO CORPORATE CENTER DR. Melville,  NY  11747
Product CodeDDR  
CFR Regulation Number866.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-19
Decision Date1998-12-23

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