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FDA 510(k)

CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE

K-Number: K885272 · 1989-03-28

ApplicantSigma Chemical Co.
Decision Date1989-03-28
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1989-03-28 under 510(k) number K885272. 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, DIBUCAINE & FLUORIDE?

CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE is a medical device that received FDA 510(k) clearance on 1989-03-28. The listed applicant is Sigma Chemical Co.. The 510(k) number is K885272.

When did CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE receive FDA 510(k) clearance?

CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE received FDA 510(k) clearance on 1989-03-28, under 510(k) number K885272.

Who is the listed applicant for CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE?

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

What is the FDA product code for CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE?

The FDA product code for CHOLINESTERASE REAGENT, DIBUCAINE & FLUORIDE is DIH.

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Other records listing Sigma Chemical 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933679SIGMA BUN REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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