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FDA 510(k)

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)

K-Number: K994006 · 2000-02-03

ApplicantAvocet Medical, Inc.
Decision Date2000-02-03
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) is the device name listed in this FDA 510(k) record. The listed applicant is Avocet Medical, Inc.. It received FDA 510(k) clearance on 2000-02-03 under 510(k) number K994006. The device is classified under product code GJS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)?

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) is a medical device that received FDA 510(k) clearance on 2000-02-03. The listed applicant is Avocet Medical, Inc.. The 510(k) number is K994006.

When did AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) receive FDA 510(k) clearance?

AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) received FDA 510(k) clearance on 2000-02-03, under 510(k) number K994006.

Who is the listed applicant for AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)?

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

What is the FDA product code for AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)?

The FDA product code for AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE) is GJS.

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 Avocet Medical, 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.

K991286AVOCET ACUSURE SYSTEMK980839AVOCET PTK980982AVOCET SYSTEM LIQUID CONTROL LEVEL 1 AND LEVEL 2

Related Devices (Code: GJS)

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.

K253188CoaguChek XS Plus SystemRoche DiagnosticsK251564microINR SystemIline Microsystems, S.L.K243543microINR SystemIline Microsystems, S.L.K230802Xprecia Prime Coagulation SystemUniversal Biosensors Pty, Ltd.K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemAbbott LaboratoriesK231711microINR SystemIline Microsystems, S.L.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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