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FDA 510(k)

WIENER LAB COLINESTERASA AA

K-Number: K023992 · 2003-02-12

ApplicantWiener Laboratories Saic
Decision Date2003-02-12
Product CodeDIH
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

WIENER LAB COLINESTERASA AA is the device name listed in this FDA 510(k) record. The listed applicant is Wiener Laboratories Saic. It received FDA 510(k) clearance on 2003-02-12 under 510(k) number K023992. 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 WIENER LAB COLINESTERASA AA?

WIENER LAB COLINESTERASA AA is a medical device that received FDA 510(k) clearance on 2003-02-12. The listed applicant is Wiener Laboratories Saic. The 510(k) number is K023992.

When did WIENER LAB COLINESTERASA AA receive FDA 510(k) clearance?

WIENER LAB COLINESTERASA AA received FDA 510(k) clearance on 2003-02-12, under 510(k) number K023992.

Who is the listed applicant for WIENER LAB COLINESTERASA AA?

The FDA 510(k) record lists Wiener Laboratories Saic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WIENER LAB COLINESTERASA AA?

The FDA product code for WIENER LAB COLINESTERASA AA is DIH.

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Other records listing Wiener Laboratories Saic 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.

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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.K013750ADVIA 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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