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)
Top companies in JPK
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2023 | R & 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 |
JPK | K843962 |
| Dec 1, 2022 | Primus 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 |
JPK | K952720 |
| Dec 1, 2022 | Primus 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 |
JPK | K952720 |
| Jan 25, 2021 | Medline 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 |
JPK | K853776 |
| Oct 5, 2020 | Becton, 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 |
JPK | K150815 |
| Apr 9, 2014 | Clinical 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 |
JPK | K024173 |
| Nov 21, 2012 | Horiba 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 |
JPK | K843962 K850755 |
| Nov 5, 2012 | Clinical 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 |
JPK | K024173 |
| Nov 5, 2012 | Clinical 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 |
JPK | K024173 |
| Nov 2, 2012 | Clinical 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 |
JPK | K024173 |
| Nov 2, 2012 | Clinical 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 |
JPK | K024173 |
| Nov 2, 2012 | Clinical 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 |
JPK | K024173 |
| Jan 17, 2009 | Quantimetrix 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 |
JPK | K010598 |
| Nov 15, 2005 | Tosoh 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 |
JPK | K952720 |
| Jul 20, 2004 | R & 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 |
JPK | K843962 |
| Mar 12, 2003 | Abbott 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 |
JPK | None listed |
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