SYNCHRON SYSTEMS CAL 5 PLUS

Calibrator, Multi-analyte Mixture

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Cal 5 Plus.

Pre-market Notification Details

Device IDK971283
510k NumberK971283
Device Name:SYNCHRON SYSTEMS CAL 5 PLUS
ClassificationCalibrator, Multi-analyte Mixture
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactSheri Hall
CorrespondentSheri Hall
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-07
Decision Date1997-06-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590180218 K971283 000

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