Biotrol-Abnormal

FDA 510(k) K760596 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK760596

Submission

Device name
Biotrol-Abnormal
Applicant
Boehringer Mannheim Corp.
Mchenry, IL, US
Received
September 7, 1976
Decision date
October 8, 1976
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
K984326Elecys Ige AssayJHR · Traditional 02/08/1999SE
K983047Accu-Chek HQ SystemLFR · Traditional 02/05/1999SE
K984419Elecsys Ige CalcheckJJY · Traditional 02/02/1999SE
K984425Modification of Preciset Serum Proteins CalibratorJIX · Traditional 01/20/1999SE
K984372Elecsys Calcheck Troponin TJJY · Traditional 12/14/1998SE
K984105Elecsys Troponin T Stat TestMMI · Traditional 12/08/1998SE
K983503Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional 12/01/1998SE
K983469Preciset Serum Proteins CalibratorJIX · Traditional 11/25/1998SE
K983185Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional 11/12/1998SE
K983510Chemstrip 101 Urine AnalyzerKQO · Special 10/27/1998SE

Questions and answers

When was Biotrol-Abnormal cleared by the FDA?

Biotrol-Abnormal (K760596) received a 510(k) decision of Substantially Equivalent on October 8, 1976, 31 days after the submission was received.

What is the product code of K760596?

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