Coagulation Arp

FDA 510(k) K790826 · Helena Laboratories

Substantially Equivalent

510(k) numberK790826

Submission

Device name
Coagulation Arp
Applicant
Helena Laboratories
Walker, MI, US
Received
April 30, 1979
Decision date
May 31, 1979
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
K213396SPIFE A1AT kitOBZ · Traditional 10/13/2022SE
K192931V8 Nexus Hemoglobin Ultrascreen, V8 AFSA2 Hemo ControlGKA · Traditional 04/19/2022SE
K131479V8 SP Normal Control, Abnormal ControlJJY · Traditional 10/07/2013SE
K100103Specialty Assayed CONTROL-2GGC · Traditional 12/15/2010SE
K061991Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional 02/23/2007SE
K061069Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional 07/06/2006SE
K061014Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special 05/10/2006SE
K050053Hemoram/Aggram AnalyzerJPA · Traditional 07/11/2005SE
K024162Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional 02/19/2003SE
K023761Plateletworks, Models Pw-A, Pw-CJOZ · Traditional 02/14/2003SE

Questions and answers

When was Coagulation Arp cleared by the FDA?

Coagulation Arp (K790826) received a 510(k) decision of Substantially Equivalent on May 31, 1979, 31 days after the submission was received.

What is the product code of K790826?

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