Company ยท US
R&D Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2016. Name variants (Inc, Corp, punctuation) are merged.
79510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPK | Mixture, Hematology Quality Control | 47 |
| GGT | Assay, Erythropoietin | 4 |
| JNM | Immunochemical, Transferrin | 4 |
| KRX | Calibrator For Cell Indices | 4 |
| GGM | Control, Hemoglobin | 3 |
| JCN | Control, Cell Counter, Normal And Abnormal | 3 |
| KSA | Calibrator For Red-Cell And White-Cell Counting | 3 |
| GKZ | Counter, Differential Cell | 2 |
| KQC | Stains, Hematology | 2 |
| FRZ | Device, Patient Transfer, Powered | 1 |
| GIF | Diluent, Blood Cell | 1 |
| GKH | Apparatus, Automated Blood Cell Diluting | 1 |
| GKR | System, Hemoglobin, Automated | 1 |
| JFB | Table, Physical Therapy, Multi Function | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 |
| KHG | Whole Blood Hemoglobin Determination | 1 |
| KJN | Brilliant Cresyl Blue | 1 |
| KRY | Calibrator For Platelet Counting | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 1, 2016 | K160606 | BC-5D Hematology Control R&D Systems, Inc. | JPK |
| Jul 24, 2013 | K130962 | R&D 5D RETIC HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Apr 28, 2011 | K101578 | R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jan 29, 2010 | K100050 | R & D SYSTEMS XERET HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Oct 28, 2009 | K091433 | R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL R&D Systems, Inc. | JPK |
| Dec 27, 2007 | K073178 | HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004 R&D Systems, Inc. | JPK |
| Nov 26, 2007 | K072846 | CSF AUTOMATED CONTROL, MODELS CSF001, CSF003 R&D Systems, Inc. | JPK |
| Nov 20, 2007 | K072268 | HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S R&D Systems, Inc. | JPK |
| Aug 20, 2007 | K072096 | CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04 R&D Systems, Inc. | JPK |
| Mar 29, 2007 | K070334 | R&D SICKLE QC CONTROL R&D Systems, Inc. | GGM |
| Jul 10, 2006 | K061511 | R&D CBC-3D + CRP HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jun 2, 2006 | K061320 | R&D LH-NRBC HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jul 12, 2005 | K051339 | R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Sep 1, 2004 | K042094 | R&D CBC-XE HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Mar 10, 2004 | K034048 | R&D GLU-LINE HEMATOLOGY CONTROL R&D Systems, Inc. | JJX |
| Feb 6, 2002 | K020229 | R & D BODY FLUID CONTROL R&D Systems, Inc. | JPK |
| Jan 22, 2002 | K013898 | R&D RET-LINE KIT R&D Systems, Inc. | JPK |
| May 11, 2001 | K010470 | R & D 4K RETIC R&D Systems, Inc. | JPK |
| Apr 3, 2001 | K010461 | ADVIA RETIC PLUS R&D Systems, Inc. | JPK |
| Mar 16, 2001 | K010409 | CBC-SF R&D Systems, Inc. | JPK |
| Jan 16, 2001 | K003991 | CD-CAL PLUS CALIBRATOR R&D Systems, Inc. | KRX |
| Jan 12, 2001 | K003874 | CBC-4K HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Dec 1, 2000 | K003534 | PENTRA 5D R&D Systems, Inc. | JPK |
| Nov 7, 2000 | K003208 | R & D 3K RETIC R&D Systems, Inc. | JPK |
| Nov 12, 1999 | K993321 | R&D HGB/GLC WHOLE BLOOD CONTROL R&D Systems, Inc. | GGM |
| Jun 17, 1999 | K991876 | SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE R&D Systems, Inc. | JPK |
| Feb 17, 1999 | K983032 | CBC-5D HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Dec 10, 1998 | K984099 | QBC CENTRIFUGAL HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jul 20, 1998 | K982231 | STATUSFLOW R&D Systems, Inc. | GKZ |
| Jul 24, 1997 | K972172 | ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION R&D Systems, Inc. | JPK |
| Jul 24, 1997 | K972170 | ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION R&D Systems, Inc. | JPK |
| May 29, 1997 | K964767 | QUANTIKINE IVD BETA-2-MICROGLOBULIN ENZYME IMMUNOASSAY (EIA( R&D Systems, Inc. | JZG |
| May 27, 1997 | K970718 | QUANTIKINE IVD STFR ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R&D Systems, Inc. | JNM |
| Apr 16, 1997 | K970331 | CBC-4K HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jul 15, 1996 | K961673 | R&D RETIC-PG HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Jul 1, 1996 | K961610 | R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC) R&D Systems, Inc. | GKZ |
| Feb 29, 1996 | K955925 | CBC-CAL PLUS HEMATOLOGY CALIBRATOR R&D Systems, Inc. | KRX |
| Oct 6, 1995 | K954137 | QBC CENTRIFUGAL HEMATOLOGY CONTROL R&D Systems, Inc. | JPK |
| Dec 12, 1994 | K943336 | RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Dec 12, 1994 | K943335 | RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Oct 7, 1994 | K942822 | CBC-LINE HEMATOLOGY LINEARITY CONTROL R&D Systems, Inc. | JPK |
| Jul 19, 1994 | K936016 | QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) R&D Systems, Inc. | GGT |
| Apr 21, 1994 | K931756 | QUANTIKINE(TM) ERYTHROPOIETIN HUMAN SERUM CONTROLS R&D Systems, Inc. | GGT |
| Mar 22, 1994 | K940089 | CBC-COBAS 5 HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Dec 6, 1993 | K934497 | CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JCN |
| Jul 20, 1993 | K931666 | QUANTIKINE(TM) ERYTHROPOIETIN/ENZ LINK IMMUN ASSAY R&D Systems, Inc. | GGT |
| Nov 27, 1991 | K913879 | CBC-8K(TM) HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Jul 9, 1991 | K912357 | 3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE R&D Systems, Inc. | KRX |
| Oct 29, 1990 | K904637 | QBC(R) CENTRIFUGAL HEMATOLOGY CONTROL/MULTIPLE R&D Systems, Inc. | JPK |
| Oct 23, 1990 | K904464 | CBC-LASER(R) HEMATOLOGY CONTROL/MULTIPLE-MODIFIED R&D Systems, Inc. | JPK |
Newest 50 of 79.
Latest recalls
| 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 |
| Jul 15, 2022 | R & D Systems, Inc. Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations in human serum and plasma. IFU, Part Number 750095 Terminated |
GGT | K931756 |
| Jan 20, 2021 | R & D Systems, Inc. Quantikine IVD Human sTfR Immunoassay (Human sTransferrin ELISA Kit (sTfR immunological test system)). An enzyme linked immunosorbent assay (ELISA) for the quantitative determination of Soluble Trans Terminated |
JNM | K970718 |
| Nov 1, 2018 | R & D Systems, Inc. Quantikine IVD ELISA, Human sTfR Immunoassay kit.
Product Usage:
The QuantikineTM IVDTM sTFR Enzyme linked immunosorbent assay is intended for the measurement of sTfR concentration in human serum or Terminated |
JNM | K970718 |
| Sep 11, 2018 | R & D Systems, Inc. R&D systems, a bio-techne brand Human Total 25-OH Vitamin D IVD ELISA Kit, REF RDKAP1971 Terminated |
MRG | K123364 |
| Sep 26, 2016 | R & D Systems, Inc. R&D Systems, Quantikine IVDsTfR Immunoassay Kit, for the quantitative determination of soluble transferrin receptor (sTfR) concentrations in human serum and plasma For in Vitro Diagnostic Use, REF DTF Terminated |
JNM | K970718 |
| 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 |