FDA.reportPublic FDA data

510(k) K781572

Device
Normal Hematology Control Unassayed
Applicant
ORTHO DIAGNOSTICS, INC.
510(k) number
K781572
Product code
JPK
Decision
Substantially Equivalent (SESE)
Decision date
1978-10-17
Date received
1978-09-14
Regulation
864.8625
Classification name
Mixture, Hematology Quality Control
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JPK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K160590XN CHECKStreck2016-12-22
K160588XN CHECK BFStreck2016-12-22
K160586XN-L CHECKStreck2016-12-22
K160606BC-5D Hematology ControlR&D Systems, Inc.2016-09-01
K141964XN CHECKStreck2014-12-05
K141957XN CHECK BFStreck2014-12-05
K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.2013-07-24
K120744XN CHECK BFStreck2012-10-19
K120742XN CHECKStreck2012-10-19
K101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLR&D Systems, Inc.2011-04-28
K100790COULTER LIN-X LINEARITY CONTROL, MODEL A81196Beckman Coulter, Inc.2010-12-21
K100607COULTER 4C-EX 300 CELL CONTROLBeckman Coulter, Inc.2010-11-18
K091303LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LVBio-Rad Laboratories2010-08-02
K100050R & D SYSTEMS XERET HEMATOLOGY CONTROLR&D Systems, Inc.2010-01-29
K091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLR&D Systems, Inc.2009-10-28