Heptrac Electronic Quality Control

FDA 510(k) K981815 · Medtronic Blood Management

Substantially Equivalent

510(k) numberK981815

Submission

Device name
Heptrac Electronic Quality Control
Applicant
Medtronic Blood Management
Parker, CO, US
Received
May 22, 1998
Decision date
July 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.

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K982755Modification of Autotransfusion Apparatus (Autolog)CAC · Traditional 08/20/1998SE
K972894Autotransfusion Appartus (Autolog)CAC · Traditional 04/27/1998SE

Questions and answers

When was Heptrac Electronic Quality Control cleared by the FDA?

Heptrac Electronic Quality Control (K981815) received a 510(k) decision of Substantially Equivalent on July 30, 1998, 69 days after the submission was received.

What is the product code of K981815?

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.