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FDA 510(k)

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE

K-Number: K914171 · 1991-12-18

ApplicantTech Intl. Co.
Decision Date1991-12-18
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE is the device name listed in this FDA 510(k) record. The listed applicant is Tech Intl. Co.. It received FDA 510(k) clearance on 1991-12-18 under 510(k) number K914171. 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 IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE?

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE is a medical device that received FDA 510(k) clearance on 1991-12-18. The listed applicant is Tech Intl. Co.. The 510(k) number is K914171.

When did IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE received FDA 510(k) clearance on 1991-12-18, under 510(k) number K914171.

Who is the listed applicant for IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE?

The FDA 510(k) record lists Tech Intl. Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE?

The FDA product code for IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASE is DIH.

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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.

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Other records listing Tech Intl. 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.

K915704AMYLASE (KINETIC) REAGENT SETK915705ACID PHOSPHATASE REAGENT SETK915707AMMONIA REAGENT SETK914158URIC ACID REAGENT SETK915706LIPASE REAGENT SETK914160CHOLESTEROL REGEANT SET

View all 13 devices →

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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