SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR

Calibrator, Primary

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Lx Systems Microalbumin Calibrator.

Pre-market Notification Details

Device IDK000331
510k NumberK000331
Device Name:SYNCHRON LX SYSTEMS MICROALBUMIN CALIBRATOR
ClassificationCalibrator, Primary
Applicant BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
ContactGail Lefebvre
CorrespondentGail Lefebvre
BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
Product CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-22
Decision Date2000-02-10

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590225346 K000331 000

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