Arantrol

FDA 510(k) K780835 · Aranco Diagnostic Laboratories, Inc.

Substantially Equivalent

510(k) numberK780835

Submission

Device name
Arantrol
Applicant
Aranco Diagnostic Laboratories, Inc.
Mchenry, IL, US
Received
May 23, 1978
Decision date
June 22, 1978
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code JPK

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K160590XN CheckJPK · Traditional Streck12/22/2016SE
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K160586Xn-L CheckJPK · Traditional Streck12/22/2016SE
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 Arantrol cleared by the FDA?

Arantrol (K780835) received a 510(k) decision of Substantially Equivalent on June 22, 1978, 30 days after the submission was received.

What is the product code of K780835?

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