Streck Laboratories, Inc.
Medical device manufacturer in La Vista, NE.
70510(k) clearances
0PMA approvals
0recalls
Device types
- JPK Mixture, Hematology Quality Control 23
- JJX Single (Specified) Analyte Controls… 9
- JJY Multi-Analyte Controls, All Kinds (Assayed) 7
- GGL Control, White-Cell 4
- GLQ Mixture, Control, White-Cell And Red-Cell… 4
- JCN Control, Cell Counter, Normal And Abnormal 4
- GHM Test, Sickle Cell 2
- KRY Calibrator For Platelet Counting 2
- KRX Calibrator For Cell Indices 2
- GJR Control, Red-Cell 2
- JKA Tubes, Vials, Systems, Serum Separators… 1
- KSA Calibrator For Red-Cell And White-Cell… 1
- LAW Theophylline Control Materials 1
- JBX Aggregrometer, Platelet 1
- KRZ Calibrator For Hemoglobin And Hematocrit… 1
- JOX Analyzer, Heparin, Automated 1
- GKL Counter, Cell, Automated (Particle Counter) 1
- JIS Calibrator, Primary 1
- JRR Regulator, Temperature 1
- GLG Platelet Counting, Manual 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K042587 | Retic-Chex for Cell-DynJPK · Traditional | 10/19/2004SE |
| K040107 | Cyto-Chex BCTJKA · Traditional | 07/27/2004SE |
| K040025 | A1C-CELLULARJJX · Traditional | 03/02/2004SE |
| K023656 | Sickle-Chex Solubility KitGHM · Traditional | 12/30/2002SE |
| K021922 | Modification to Para 5XJPK · Special | 06/25/2002SE |
| K020469 | Cal-Chex CD PlusKRX · Traditional | 04/04/2002SE |
| K013316 | Sickle-ChexGHM · Traditional | 11/06/2001SE |
| K011410 | Para 5XJPK · Traditional | 06/26/2001SE |
| K001443 | Sugar Chex OneJJX · Traditional | 06/29/2000SE |
| K000945 | Para 12 Plus ReticsGLQ · Traditional | 04/18/2000SE |
| K000115 | Retic Chex LinearityJPK · Traditional | 03/27/2000SE |
| K000076 | Cell-ChexGJR · Traditional | 03/03/2000SE |
| K994388 | Xe CheckGLQ · Traditional | 01/14/2000SE |
| K993825 | Para Tech Plus ReticsJCN · Traditional | 11/30/1999SE |
| K993126 | Cd-Chex CD 34GGL · Traditional | 11/26/1999SE |
| K992887 | Stak-Chex Plus ReticsGLQ · Traditional | 11/22/1999SE |
| K982290 | Chem-Chex Stat (New)JJY · Traditional | 07/22/1998SE |
| K960894 | Cd-Chex + RBCGGL · Traditional | 05/24/1996SE |
| K961195 | Chem-Chex StatJJY · Traditional | 05/15/1996SE |
| K960557 | Calibration Verification Assessment (Cva)JPK · Traditional | 04/03/1996SE |
| K952245 | Sf-CheckJPK · Traditional | 09/01/1995SE |
| K943268 | SCS-1000 (Sysmex Calibrator System)KSA · Traditional | 12/15/1994SE |
| K942632 | TNT Troponin TJJX · Traditional | 09/09/1994SE |
| K931825 | Cd-Chex CD4 LowGGL · Traditional | 06/06/1994SE |
| K935196 | Para 5 DiffJPK · Traditional | 04/05/1994SE |
| K940181 | Se-CheckJPK · Traditional | 03/09/1994SE |
| K933844 | Para 4 PlusJJY · Traditional | 12/27/1993SE |
| K925479 | Sugar Chex Linearity for the One TouchJJX · Traditional | 01/28/1993SE |
| K923971 | Qc-ChexJPK · Traditional | 11/16/1992SE |
| K920223 | Chem Chex Theophylline ControlLAW · Traditional | 06/10/1992SE |
| K920997 | Cd-ChexGGL · Traditional | 05/31/1992SE |
| K920350 | Chem-Chem Multi-Analyte (Modified)JJY · Traditional | 03/23/1992SE |
| K913687 | Chem-ChexJJY · Traditional | 09/19/1991SE |
| K911582 | Stak-ChexJCN · Traditional | 05/28/1991SE |
| K905524 | Retic-ChexJPK · Traditional | 02/20/1991SE |
| K905389 | Chem-Chex LipidJJY · Traditional | 12/26/1990SE |
| K903147 | Chem-Chex-AltJJX · Traditional | 08/09/1990SE |
| K902867 | Chem-Chex BilirubinJJX · Traditional | 07/16/1990SE |
| K901875 | Para 12 PlusJCN · Traditional | 05/30/1990SE |
| K900993 | Chem-ChexJJY · Traditional | 04/16/1990SE |
| K900484 | Ret-CheckGJR · Traditional | 03/09/1990SE |
| K896154 | Para Tech for Technicon H-1JCN · Traditional | 11/09/1989SE |
| K890767 | Ne-CheckJPK · Traditional | 03/23/1989SE |
| K881829 | Pat Platelet Aggregation TestJBX · Traditional | 07/01/1988SE |
| K873105 | Reflo-Chex, a Cholesterol Reference ControlJJX · Traditional | 09/16/1987SE |
| K852992 | Para Check (Aka Eight Check-C)JPK · Traditional | 10/10/1985SE |
| K852107 | Sickle-Chex · Traditional | 07/05/1985SE |
| K851043 | Sugar-Chex IIJJX · Traditional | 04/29/1985SE |
| K851042 | Sugar-ChexJJX · Traditional | 04/29/1985SE |
| K843093 | Retic-ChexJPK · Traditional | 10/23/1984SE |
| K841531 | Para-TekJPK · Traditional | 07/27/1984SE |
| K842017 | Para 4JPK · Traditional | 06/26/1984SE |
| K840261 | Cal-Chex, a Hematology CalibratorKRZ · Traditional | 02/21/1984SE |
| K831094 | Para LasarJPK · Traditional | 06/08/1983SE |
| K823498 | Para 12GLQ · Traditional | 12/28/1982SE |
| K813011 | HepaquantJOX · Traditional | 01/26/1982SE |
| K811741 | Cell-Chex RBCKRX · Traditional | 09/24/1981SE |
| K802636 | Platelet Counting KitGKL · Traditional | 12/11/1980SE |
| K800361 | Hemato-ChexJPK · Traditional | 04/04/1980SE |
| K800062 | Pipet Calibration KitJIS · Traditional | 02/11/1980SE |
| K792467 | Platelet-Chex for Blood CentersJPK · Traditional | 12/31/1979SE |
| K791228 | PARA-8JPK · Traditional | 08/03/1979SE |
| K791227 | PARA-7JPK · Traditional | 08/03/1979SE |
| K791226 | Platelet-Chex PlusJPK · Traditional | 08/03/1979SE |
| K781601 | Tekni-CalKRY · Traditional | 10/10/1978SE |
| K781133 | Pc-CalibratorKRY · Traditional | 08/14/1978SE |
| K780757 | KRYORACK/4JRR · Traditional | 06/06/1978SE |
| K780140 | Cell-ChexJPK · Traditional | 03/27/1978SE |
| K772105 | Platelet KitGLG · Traditional | 11/30/1977SE |
| K770020 | Platelet-Chex-HumanJPK · Traditional | 02/16/1977SE |