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FDA 510(k)

OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)

K-Number: K030045 · 2003-02-21

ApplicantOlympus America, Inc.
Decision Date2003-02-21
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) is the device name listed in this FDA 510(k) record. The listed applicant is Olympus America, Inc.. It received FDA 510(k) clearance on 2003-02-21 under 510(k) number K030045. 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 OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)?

OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) is a medical device that received FDA 510(k) clearance on 2003-02-21. The listed applicant is Olympus America, Inc.. The 510(k) number is K030045.

When did OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) receive FDA 510(k) clearance?

OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) received FDA 510(k) clearance on 2003-02-21, under 510(k) number K030045.

Who is the listed applicant for OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)?

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

What is the FDA product code for OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)?

The FDA product code for OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114) is DIH.

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Other records listing Olympus America, Inc. 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.

K111788ENDOEYE HD IIK081615OLYMPUS CEA - CARCINOEMBRYONIC ANTIGENK073487OLYMPUS IGM REAGENTK073490OLYMPUS IGG REAGENTK073489OLYMPUS IGA REAGENTK062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98

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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. SrlK023992WIENER LAB COLINESTERASA AAWiener Laboratories SaicK013750ADVIA 1650 CHOLINESTERASE ASSAYBayer Diagnostics Corp.K002792CARESIDE CHOLINESTERASECareside, Inc.

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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