EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM

Anti-glutamate Receptor (type Nmda) Ifa

EUROIMMUN US INC

The following data is part of a premarket notification filed by Euroimmun Us Inc with the FDA for Euroimmun Hippocampus/cerebellum/glutamate Receptor/ifa Biochip Mosaic Test System.

Pre-market Notification Details

Device IDK100017
510k NumberK100017
Device Name:EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM
ClassificationAnti-glutamate Receptor (type Nmda) Ifa
Applicant EUROIMMUN US INC 95 WASHINGTON ST Morristown,  NJ  07960
ContactKathryn Kohl
CorrespondentKathryn Kohl
EUROIMMUN US INC 95 WASHINGTON ST Morristown,  NJ  07960
Product CodeOSK  
CFR Regulation Number866.5660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-01-04
Decision Date2010-09-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04049016092575 K100017 000
04049016092568 K100017 000
04049016092551 K100017 000
04049016092544 K100017 000
04049016092537 K100017 000

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