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FDA 510(k)

CARESIDE CHOLINESTERASE

K-Number: K002792 · 2000-11-08

ApplicantCareside, Inc.
Decision Date2000-11-08
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

CARESIDE CHOLINESTERASE is the device name listed in this FDA 510(k) record. The listed applicant is Careside, Inc.. It received FDA 510(k) clearance on 2000-11-08 under 510(k) number K002792. 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 CARESIDE CHOLINESTERASE?

CARESIDE CHOLINESTERASE is a medical device that received FDA 510(k) clearance on 2000-11-08. The listed applicant is Careside, Inc.. The 510(k) number is K002792.

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

CARESIDE CHOLINESTERASE received FDA 510(k) clearance on 2000-11-08, under 510(k) number K002792.

Who is the listed applicant for CARESIDE CHOLINESTERASE?

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

What is the FDA product code for CARESIDE CHOLINESTERASE?

The FDA product code for CARESIDE CHOLINESTERASE is DIH.

Related Clinical Trials

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.

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Other records listing Careside, 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.

K020484CARESIDE LDHK020486CARESIDE GGTK020487CARESIDE ALTK020488CARESIDE TRGLYCERIDEK001462CARESIDE HEMOGLOBINK993771CARESIDE DIRECT BILIRUBIN

View all 22 devices →

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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