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Panels › Hematology › Product code JPK · Class 2

Mixture, Hematology Quality Control

Regulation 864.8625

0510(k)s in 12 months (192 all time)
0recalls in 12 months (16 all time)
15recalls that name a 510(k)
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Top companies in JPK

DateFirm and productCodeLinked 510(k)
Jan 19, 2023R & D Systems, Inc.
R&D CBC-3D Hematology Control: (1) CBC-3D Normal Pack Hematology Control, REF 3D501, containing 10 x 2.0mL Control N; (2) CBC-3D TRI PACK Hematology Control, REF 3D503, containing 4 x 2.0 mL Control
Terminated
JPKK843962
Dec 1, 2022Primus Corporation dba Trinity Biotech
Trinity Biotech HbA1c (GHb) Contorls Kit, 500uL (Levels I & II), REF 01-04-0020, Part number 05-01-0040B, A1c analysis
Terminated
JPKK952720
Dec 1, 2022Primus Corporation dba Trinity Biotech
A. MENARINI diagnostics Hb 9210 PREMIER, LEVEL1, LEVEL II, Hemoglobin A1c Controls for hemoglobin A1c Assay, REF 45052, part number 05-01-0926, A1c analysis
Terminated
JPKK952720
Jan 25, 2021Medline Industries Inc
RNA MEDICAL, QCHGB HEMOGLOBIN CONTROL, MULTI, REF QC HGB - Product Usage: monitoring the performance of Hemocue Hemoglobin Analyzers. It provides a convenient method of performing periodic QC checks t
Terminated
JPKK853776
Oct 5, 2020Becton, Dickinson and Company, BD Biosciences
BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product Usage: intended as a complete process control for immunophenotyping by flow cytometry.
Terminated
JPKK150815
Apr 9, 2014Clinical Diagnostic Solutions
Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Terminated
JPKK024173
Nov 21, 2012Horiba Instruments, Inc dba Horiba Medical
Minotrol 16, Model Numbers: 2043748, 2043752, 2043756, Lot Number: MX090(Levels: Low, Normal, and High). Minotrol 16 is a tri-level control intended for in vitro diagnostic use in monitoring the accu
Terminated
JPKK843962
K850755
Nov 5, 2012Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Terminated
JPKK024173
Nov 5, 2012Clinical Diagnostic Solutions
Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Terminated
JPKK024173
Nov 2, 2012Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Terminated
JPKK024173
Nov 2, 2012Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Terminated
JPKK024173
Nov 2, 2012Clinical Diagnostic Solutions
Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Terminated
JPKK024173
Jan 17, 2009Quantimetrix Corporation
Quantimetrix Synovialscopics Synovial Fluid Control. Synovialscopics is a plastic bottle Synovial fluid cell count control. It is a control for monitoring total cell counts in patient Synovial flui
Terminated
JPKK010598
Nov 15, 2005Tosoh Bioscience, Inc.
Tosoh brand Glycohemoglobin A1c Controls I & II, Catalog Number: 992133; Product is distributed by TOSOH Bioscience Inc., 347 Oyster Point Blvd. Suite 201, South San Francisco, CA 94080.
Terminated
JPKK952720
Jul 20, 2004R & D Systems,Inc
ABX Diagnostics Minotrol 16 Hematology Controls, Normal and High, in vials distributed by ABX Diagnostics, Irvine, CA; and Horiba LC-TROL 16 (Hematology Reference Controls), Normal and High, in vials
Terminated
JPKK843962
Mar 12, 2003Abbott Laboratories
Abbott brand DILUENT/SHEATH, CELL-DYN 4000 System CELL-DYN REAGENT PART A Model/List Number 01H77-01 (4x3.8L), 01H75-01A (3.8L)
Terminated
JPKNone listed

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