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FDA 510(k)

AVOCET ACUSURE SYSTEM

K-Number: K991286 · 1999-11-18

ApplicantAvocet Medical, Inc.
Decision Date1999-11-18
Product CodeGJS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AVOCET ACUSURE SYSTEM 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 1999-11-18 under 510(k) number K991286. 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 SYSTEM?

AVOCET ACUSURE SYSTEM is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is Avocet Medical, Inc.. The 510(k) number is K991286.

When did AVOCET ACUSURE SYSTEM receive FDA 510(k) clearance?

AVOCET ACUSURE SYSTEM received FDA 510(k) clearance on 1999-11-18, under 510(k) number K991286.

Who is the listed applicant for AVOCET ACUSURE SYSTEM?

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 SYSTEM?

The FDA product code for AVOCET ACUSURE SYSTEM 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.

K994006AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)K980839AVOCET 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

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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