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FDA 510(k)

CHOLINESTERASE GEN.2 TEST SYSTEM

K-Number: K061093 · 2006-07-03

ApplicantRoche Diagnostics Corp.
Decision Date2006-07-03
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHOLINESTERASE GEN.2 TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2006-07-03 under 510(k) number K061093. 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 CHOLINESTERASE GEN.2 TEST SYSTEM?

CHOLINESTERASE GEN.2 TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2006-07-03. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K061093.

When did CHOLINESTERASE GEN.2 TEST SYSTEM receive FDA 510(k) clearance?

CHOLINESTERASE GEN.2 TEST SYSTEM received FDA 510(k) clearance on 2006-07-03, under 510(k) number K061093.

Who is the listed applicant for CHOLINESTERASE GEN.2 TEST SYSTEM?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLINESTERASE GEN.2 TEST SYSTEM?

The FDA product code for CHOLINESTERASE GEN.2 TEST SYSTEM is DIH.

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Other records listing Roche Diagnostics Corp. as applicant

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.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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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.

K103373SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722Beckman Coulter, Inc.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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