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FDA 510(k)

TEST-MATE CHE CHOLINESTERASE TEST SYSTEM

K-Number: K961656 · 1996-11-26

ApplicantEqm Research, Inc.
Decision Date1996-11-26
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

TEST-MATE CHE CHOLINESTERASE TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Eqm Research, Inc.. It received FDA 510(k) clearance on 1996-11-26 under 510(k) number K961656. 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 TEST-MATE CHE CHOLINESTERASE TEST SYSTEM?

TEST-MATE CHE CHOLINESTERASE TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1996-11-26. The listed applicant is Eqm Research, Inc.. The 510(k) number is K961656.

When did TEST-MATE CHE CHOLINESTERASE TEST SYSTEM receive FDA 510(k) clearance?

TEST-MATE CHE CHOLINESTERASE TEST SYSTEM received FDA 510(k) clearance on 1996-11-26, under 510(k) number K961656.

Who is the listed applicant for TEST-MATE CHE CHOLINESTERASE TEST SYSTEM?

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

What is the FDA product code for TEST-MATE CHE CHOLINESTERASE TEST SYSTEM?

The FDA product code for TEST-MATE CHE CHOLINESTERASE TEST SYSTEM is DIH.

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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

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

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