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FDA 510(k)

RAICHEM CHOLINESTERASE REAGENT

K-Number: K862168 · 1986-06-27

ApplicantReagents Applications, Inc.
Decision Date1986-06-27
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAICHEM CHOLINESTERASE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Reagents Applications, Inc.. It received FDA 510(k) clearance on 1986-06-27 under 510(k) number K862168. 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 RAICHEM CHOLINESTERASE REAGENT?

RAICHEM CHOLINESTERASE REAGENT is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Reagents Applications, Inc.. The 510(k) number is K862168.

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

RAICHEM CHOLINESTERASE REAGENT received FDA 510(k) clearance on 1986-06-27, under 510(k) number K862168.

Who is the listed applicant for RAICHEM CHOLINESTERASE REAGENT?

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

What is the FDA product code for RAICHEM CHOLINESTERASE REAGENT?

The FDA product code for RAICHEM CHOLINESTERASE REAGENT is DIH.

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Other records listing Reagents Applications, Inc. as applicant

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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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