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FDA 510(k)

CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE

K-Number: K880049 · 1989-01-27

ApplicantSclavo, Inc.
Decision Date1989-01-27
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1989-01-27 under 510(k) number K880049. 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 - BUTYRYTHIOCHOLINE SUBSTRATE?

CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE is a medical device that received FDA 510(k) clearance on 1989-01-27. The listed applicant is Sclavo, Inc.. The 510(k) number is K880049.

When did CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE receive FDA 510(k) clearance?

CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE received FDA 510(k) clearance on 1989-01-27, under 510(k) number K880049.

Who is the listed applicant for CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE?

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

What is the FDA product code for CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE?

The FDA product code for CHOLINESTERASE - BUTYRYTHIOCHOLINE SUBSTRATE is DIH.

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Other records listing Sclavo, 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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