SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS

Alkaline Picrate, Colorimetry, Creatinine

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Lx20 Clinical Systems, Creatinine Test Systems.

Pre-market Notification Details

Device IDK071277
510k NumberK071277
Device Name:SYNCHRON LX20 CLINICAL SYSTEMS, CREATININE TEST SYSTEMS
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea,  CA  92822 -8000
ContactTara M Viviani
CorrespondentTara M Viviani
BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea,  CA  92822 -8000
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-05-07
Decision Date2007-06-01
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590233525 K071277 000
15099590233426 K071277 000
15099590233419 K071277 000
15099590233402 K071277 000

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