Avocet PT

FDA 510(k) K980839 · Avocet Medical, Inc.

Substantially Equivalent

510(k) numberK980839

Submission

Device name
Avocet PT
Applicant
Avocet Medical, Inc.
Campbell, CA, US
Received
March 4, 1998
Decision date
September 30, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JPA – System, Multipurpose For In Vitro Coagulation Studies
Device class
Class II (moderate risk)
Regulation
21 CFR 864.5425
Specialty
Hematology

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More from Accriva Diagnostics, Inc.

510(k)DeviceDecision
K994006Avocet Acusure (for Patient Self-Testing) and Avocet Acusure Pro (for Professional Use)GJS · Traditional 02/03/2000SE
K991286Avocet Acusure SystemGJS · Traditional 11/18/1999SE
K980982Avocet System Liquid Control Level 1 and Level 2GGN · Traditional 04/16/1998SE

Questions and answers

When was Avocet PT cleared by the FDA?

Avocet PT (K980839) received a 510(k) decision of Substantially Equivalent on September 30, 1998, 210 days after the submission was received.

What is the product code of K980839?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.