Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use)

FDA 510(k) K994006 · Avocet Medical, Inc.

Substantially Equivalent

510(k) numberK994006

Submission

Device name
Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use)
Applicant
Avocet Medical, Inc.
San Jose, CA, US
Received
November 24, 1999
Decision date
February 3, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GJS – Test, Time, Prothrombin
Device class
Class II (moderate risk)
Regulation
21 CFR 864.7750
Specialty
Hematology

Other 510(k)s with product code GJS

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K253188CoaguChek XS Plus SystemGJS · Special Roche Diagnostics10/24/2025SE
K251564microINR SystemGJS · Traditional Iline Microsystems, S.L.07/21/2025SE
K243543microINR SystemGJS · Traditional Iline Microsystems, S.L.02/27/2025SE
K230802Xprecia Prime Coagulation SystemGJS · Dual Track Universal Biosensors Pty, Ltd.03/15/2024SE
K220282i-STAT PTplus Cartridge with the i-STAT 1 SystemGJS · Traditional Abbott Laboratories07/14/2023SE
K231711microINR SystemGJS · Special Iline Microsystems, S.L.07/11/2023SE
K211485STA- NeoPTimalGJS · Traditional Diagnostica Stago S.A.S12/23/2022SE
K212779Coag-Sense Prothrombin (PT) / INR Monitoring System for Patient Self-TestingGJS · Special Coagusense, Inc.10/05/2022SE
K213426HemosIL ReadiPlasTinGJS · Traditional Instrumentation Laboratory CO08/16/2022SE
K201185microINR SystemGJS · Traditional Iline Microsystems, S.L.12/18/2020SE

More from Iline Microsystems, S.L.

510(k)DeviceDecision
K991286Avocet Acusure SystemGJS · Traditional 11/18/1999SE
K980839Avocet PTJPA · Traditional 09/30/1998SE
K980982Avocet System Liquid Control Level 1 and Level 2GGN · Traditional 04/16/1998SE

Questions and answers

When was Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use) cleared by the FDA?

Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use) (K994006) received a 510(k) decision of Substantially Equivalent on February 3, 2000, 71 days after the submission was received.

What is the product code of K994006?

The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.