SYNCHRON TOTAL PROTEIN TEST --MODIFIED

Biuret (colorimetric), Total Protein

BECKMAN INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Total Protein Test --modified.

Pre-market Notification Details

Device IDK922467
510k NumberK922467
Device Name:SYNCHRON TOTAL PROTEIN TEST --MODIFIED
ClassificationBiuret (colorimetric), Total Protein
Applicant BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
ContactWilliam T Ryan
CorrespondentWilliam T Ryan
BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD., W-337 BOX 8000 Brea,  CA  92622 -8000
Product CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-05-14
Decision Date1992-11-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590575151 K922467 000

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