SYNCHRON SYSTEMS DRUG CALIBRATOR 2

Calibrators, Drug Specific

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Drug Calibrator 2.

Pre-market Notification Details

Device IDK993473
510k NumberK993473
Device Name:SYNCHRON SYSTEMS DRUG CALIBRATOR 2
ClassificationCalibrators, Drug Specific
Applicant BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea,  CA  92822
ContactGail Lefebvre
CorrespondentGail Lefebvre
BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea,  CA  92822
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-14
Decision Date1999-11-26
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590200039 K993473 000

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