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FDA 510(k)

CHOLINESTERASE REAGENT

K-Number: K791725 · 1979-10-17

ApplicantGilford Diagnostics
Decision Date1979-10-17
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHOLINESTERASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Diagnostics. It received FDA 510(k) clearance on 1979-10-17 under 510(k) number K791725. 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 REAGENT?

CHOLINESTERASE REAGENT is a medical device that received FDA 510(k) clearance on 1979-10-17. The listed applicant is Gilford Diagnostics. The 510(k) number is K791725.

When did CHOLINESTERASE REAGENT receive FDA 510(k) clearance?

CHOLINESTERASE REAGENT received FDA 510(k) clearance on 1979-10-17, under 510(k) number K791725.

Who is the listed applicant for CHOLINESTERASE REAGENT?

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

What is the FDA product code for CHOLINESTERASE REAGENT?

The FDA product code for CHOLINESTERASE REAGENT is DIH.

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Other records listing Gilford Diagnostics 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.

K832094BILIRUBIN CALIBRATORS & CONTROLK831844DIRECT BILIRUBIN REAGENTK831843GILCHEM TOTAL BILIRUBIN REAGENTK823709TRIGLYCERIDE REAGENT (UV)K822739AHBDK822334BILIRUBIN CALIBRATORS

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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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