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FDA 510(k)

IL TEST CHOLINESTERASE

K-Number: K943367 · 1996-02-05

ApplicantInstrumentation Laboratory CO
Decision Date1996-02-05
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IL TEST CHOLINESTERASE is the device name listed in this FDA 510(k) record. The listed applicant is Instrumentation Laboratory CO. It received FDA 510(k) clearance on 1996-02-05 under 510(k) number K943367. 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 IL TEST CHOLINESTERASE?

IL TEST CHOLINESTERASE is a medical device that received FDA 510(k) clearance on 1996-02-05. The listed applicant is Instrumentation Laboratory CO. The 510(k) number is K943367.

When did IL TEST CHOLINESTERASE receive FDA 510(k) clearance?

IL TEST CHOLINESTERASE received FDA 510(k) clearance on 1996-02-05, under 510(k) number K943367.

Who is the listed applicant for IL TEST CHOLINESTERASE?

The FDA 510(k) record lists Instrumentation Laboratory CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IL TEST CHOLINESTERASE?

The FDA product code for IL TEST CHOLINESTERASE is DIH.

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Other records listing Instrumentation Laboratory CO 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.

K221359ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMK223187HemosIL Liquid Anti-XaK223090GEM Premier ChemSTATK223402HemosIL von Willebrand Factor AntigenK213464HemosIL Liquid Anti-XaK213426HemosIL ReadiPlasTin

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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.K051444SENTINEL CHOLINESTERASE LIQUIDSentinel Ch. SrlK030045OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)Olympus America, Inc.K023992WIENER LAB COLINESTERASA AAWiener Laboratories SaicK013750ADVIA 1650 CHOLINESTERASE ASSAYBayer Diagnostics Corp.

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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