MICROSCAN(R) MICROSTREP PLUS(R)

Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems

SIEMENS HEALTHCARE DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics, Inc. with the FDA for Microscan(r) Microstrep Plus(r).

Pre-market Notification Details

Device IDK111677
510k NumberK111677
Device Name:MICROSCAN(R) MICROSTREP PLUS(R)
ClassificationInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
Applicant SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
ContactJenifer Dawson Driscoll
CorrespondentJenifer Dawson Driscoll
SIEMENS HEALTHCARE DIAGNOSTICS, INC. 1584 ENTERPRISE BLVD. West Sacramento,  CA  95691
Product CodeLRG  
Subsequent Product CodeJWY
Subsequent Product CodeLTW
CFR Regulation Number866.1640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-06-15
Decision Date2011-08-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590655754 K111677 000

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