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FDA 510(k)

SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT

K-Number: K041643 · 2004-08-18

ApplicantBeckman Coulter, Inc.
Decision Date2004-08-18
Product CodeCEO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2004-08-18 under 510(k) number K041643. The device is classified under product code CEO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT?

SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT is a medical device that received FDA 510(k) clearance on 2004-08-18. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K041643.

When did SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT receive FDA 510(k) clearance?

SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT received FDA 510(k) clearance on 2004-08-18, under 510(k) number K041643.

Who is the listed applicant for SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT?

The FDA product code for SYNCHRON SYSTEMS PHOSPHORUS (PHS) REAGENT is CEO.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: CEO)

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K100263ELITECH CLINICAL SYSTEMS PHOSPHORUS, URIC ACID MONO SL AND UREA UV SL REAGENTSSeppim S.A.S.K072141S40 CLINICAL ANALYZER, S TEST IP, S TEST UAAlfa Wassermann Diagnostic Technologies, Inc.K030015ATAC PAK PHOSPHORUS REAGENTElan DiagnosticsK022312PICCOLO PHOSPHORUS TEST SYSTEMAbaxis, Inc.K013095WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311Wiener Laboratories SaicK003912PHOSPHORUS REAGENTJas Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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