SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT

Phosphomolybdate (colorimetric), Inorganic Phosphorus

BECKMAN COULTER, INC.

The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Phosphorus (phs) Reagent.

Pre-market Notification Details

Device IDK041643
510k NumberK041643
Device Name:SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT
ClassificationPhosphomolybdate (colorimetric), Inorganic Phosphorus
Applicant BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea,  CA  92822
ContactMary Beth Tang
CorrespondentMary Beth Tang
BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea,  CA  92822
Product CodeCEO  
CFR Regulation Number862.1580 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-17
Decision Date2004-08-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
15099590201364 K041643 000

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