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FDA 510(k)

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722

K-Number: K103373 · 2011-02-07

ApplicantBeckman Coulter, Inc.
Decision Date2011-02-07
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 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 2011-02-07 under 510(k) number K103373. The device is classified under product code DIH. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722?

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 is a medical device that received FDA 510(k) clearance on 2011-02-07. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K103373.

When did SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 receive FDA 510(k) clearance?

SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 received FDA 510(k) clearance on 2011-02-07, under 510(k) number K103373.

Who is the listed applicant for SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722?

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 CHOLINESTERASE (CHEX) MODEL A53722?

The FDA product code for SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 is DIH.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: DIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061093CHOLINESTERASE GEN.2 TEST SYSTEMRoche Diagnostics Corp.K051444SENTINEL CHOLINESTERASE LIQUIDSentinel Ch. SrlK030045OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)Olympus America, Inc.K023992WIENER LAB COLINESTERASA AAWiener Laboratories SaicK013750ADVIA 1650 CHOLINESTERASE ASSAYBayer Diagnostics Corp.K002792CARESIDE CHOLINESTERASECareside, 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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