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FDA 510(k)

SENTINEL CHOLINESTERASE LIQUID

K-Number: K051444 · 2005-06-20

ApplicantSentinel Ch. Srl
Decision Date2005-06-20
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SENTINEL CHOLINESTERASE LIQUID is the device name listed in this FDA 510(k) record. The listed applicant is Sentinel Ch. Srl. It received FDA 510(k) clearance on 2005-06-20 under 510(k) number K051444. 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 SENTINEL CHOLINESTERASE LIQUID?

SENTINEL CHOLINESTERASE LIQUID is a medical device that received FDA 510(k) clearance on 2005-06-20. The listed applicant is Sentinel Ch. Srl. The 510(k) number is K051444.

When did SENTINEL CHOLINESTERASE LIQUID receive FDA 510(k) clearance?

SENTINEL CHOLINESTERASE LIQUID received FDA 510(k) clearance on 2005-06-20, under 510(k) number K051444.

Who is the listed applicant for SENTINEL CHOLINESTERASE LIQUID?

The FDA 510(k) record lists Sentinel Ch. Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SENTINEL CHOLINESTERASE LIQUID?

The FDA product code for SENTINEL CHOLINESTERASE LIQUID is DIH.

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Other records listing Sentinel Ch. Srl 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.

K070971MODIFICATION TO SENTINEL CLIN CHEM CALK051447SENTINEL PANCREATIC AMYLASEK051114SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAYK051111SENTINEL UIBC LIQUIDK051452SENTINEL CLIN CHEM CALK051456SENTINEL CERULOPLASMIN

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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.K061093CHOLINESTERASE GEN.2 TEST SYSTEMRoche Diagnostics Corp.K030045OLYMPUS 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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