VIGIL PROTEIN CONTROL

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 Vigil Protein Control.

Pre-market Notification Details

Device IDK982224
510k NumberK982224
Device Name:VIGIL PROTEIN CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea,  CA  92822 -8000
ContactRichard T Ross
CorrespondentRichard T Ross
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 Received1998-06-24
Decision Date1998-07-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590226916 K982224 000
15099590223045 K982224 000
15099590222611 K982224 000

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