IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT

System, Test, Rheumatoid Factor

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage System Rheumatoid Factor (rf) Reagent.

Pre-market Notification Details

Device IDK963048
510k NumberK963048
Device Name:IMMAGE SYSTEM RHEUMATOID FACTOR (RF) REAGENT
ClassificationSystem, Test, Rheumatoid Factor
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactAnnette Hellie
CorrespondentAnnette Hellie
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-06
Decision Date1996-11-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590226947 K963048 000

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