SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS

Calibrators, Drug Mixture

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Drug Calibration 3 Plus.

Pre-market Notification Details

Device IDK971287
510k NumberK971287
Device Name:SYNCHRON SYSTEMS DRUG CALIBRATION 3 PLUS
ClassificationCalibrators, Drug 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 CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-04-07
Decision Date1997-05-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590222222 K971287 000

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