VIGIL LIPID CONTROL

Multi-analyte Controls, All Kinds (assayed)

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Vigil Lipid Control.

Pre-market Notification Details

Device IDK974452
510k NumberK974452
Device Name:VIGIL LIPID CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea,  CA  92821 -6208
ContactRichard T Ross
CorrespondentRichard T Ross
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea,  CA  92821 -6208
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-11-25
Decision Date1997-12-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590222925 K974452 000
15099590222918 K974452 000
15099590222901 K974452 000
15099590221270 K974452 000

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