SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS

Multi-analyte Controls, All Kinds (assayed)

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Op 300 Low And High Urine Controls.

Pre-market Notification Details

Device IDK993023
510k NumberK993023
Device Name:SYNCHRON SYSTEMS OP 300 LOW AND HIGH URINE CONTROLS
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
ContactGail L Efebvre
CorrespondentGail L Efebvre
BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-09
Decision Date1999-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590222000 K993023 000
15099590221997 K993023 000

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