Fetaltrol

FDA 510(k) K002511 · Trillium Diagnostics, LLC

Substantially Equivalent

510(k) numberK002511

Submission

Device name
Fetaltrol
Applicant
Trillium Diagnostics, LLC
Portland, ME, US
Received
August 15, 2000
Decision date
September 11, 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
JPK – Mixture, Hematology Quality Control
Device class
Class II (moderate risk)
Regulation
21 CFR 864.8625
Specialty
Hematology

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K160606BC-5D Hematology ControlJPK · Traditional R&D Systems, Inc.09/01/2016SE
K141964XN CheckJPK · Traditional Streck12/05/2014SE
K141957XN Check BFJPK · Traditional Streck12/05/2014SE
K130962R&D 5D Retic Hematology ControlJPK · Special R&D Systems, Inc.07/24/2013SE
K120744XN Check BFJPK · Traditional Streck10/19/2012SE
K120742XN CheckJPK · Traditional Streck10/19/2012SE
K101578R&D Systems Body Fluid-I Hematology ControlJPK · Traditional R&D Systems, Inc.04/28/2011SE

Questions and answers

When was Fetaltrol cleared by the FDA?

Fetaltrol (K002511) received a 510(k) decision of Substantially Equivalent on September 11, 2000, 27 days after the submission was received.

What is the product code of K002511?

The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.