Ortho Hemotology Control-Normal

FDA 510(k) K803083 · Ortho Instruments

Substantially Equivalent

510(k) numberK803083

Submission

Device name
Ortho Hemotology Control-Normal
Applicant
Ortho Instruments
Mchenry, IL, US
Received
December 5, 1980
Decision date
December 31, 1980
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

510(k)DeviceApplicantDecision
K160590XN CheckJPK · Traditional Streck12/22/2016SE
K160588XN Check BFJPK · Traditional Streck12/22/2016SE
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

More from R&D Systems, Inc.

510(k)DeviceDecision
K803084Ortho Hematology Control Abnormal LowJPK · Traditional 12/31/1980SE
K803073Ortho Hematology ControlJPK · Traditional 12/31/1980SE
K802094Ortho SpectrumGKL · Traditional 10/10/1980SE
K801545Ortho Automated Cell CounterGKL · Traditional 09/09/1980SE
K781146Hemac Laser Hematology SystemGKL · Traditional 09/14/1978SE

Questions and answers

When was Ortho Hemotology Control-Normal cleared by the FDA?

Ortho Hemotology Control-Normal (K803083) received a 510(k) decision of Substantially Equivalent on December 31, 1980, 26 days after the submission was received.

What is the product code of K803083?

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