SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS

Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Alcohol Reagent And Calibrators.

Pre-market Notification Details

Device IDK000410
510k NumberK000410
Device Name:SYNCHRON SYSTEMS ALCOHOL REAGENT AND CALIBRATORS
ClassificationEnzymatic Method, Alcohol Dehydrogenase, Ultraviolet
Applicant BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
ContactLucinda Stockert
CorrespondentLucinda Stockert
BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
Product CodeDMT  
CFR Regulation Number862.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-08
Decision Date2000-04-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590223335 K000410 000
15099590222079 K000410 000

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