Sterling Diagnostics, Inc.
Medical device manufacturer in Sterling Heights, MI.
41510(k) clearances
0PMA approvals
9recalls
Device types
- CEK Biuret (Colorimetric), Total Protein 2
- CDT Lipase Hydrolysis/Glycerol Kinase Enzyme… 2
- CDW Diacetyl-Monoxime, Urea Nitrogen 1
- CEI Uranyl Acetate/Zinc Acetate, Sodium 1
- CFG Oil Emulsion/Thymolphthalein (Titrimetric)… 1
- JIY Photometric Method, Iron (Non-Heme) 1
- CKE Acid Phosphatase, Thymolphthale… 1
- KHG Whole Blood Hemoglobin Determination 1
- CJA Amyloclastic, Amylase 1
- CFH Tetrazolium Int Dye-Diaphorase, Lactate… 1
- GHM Test, Sickle Cell 1
- CIX Bromcresol Green Dye-Binding, Albumin 1
- CGA Glucose Oxidase, Glucose 1
- CGX Alkaline Picrate, Colorimetry, Creatinine 1
- CIO Thymolphthalein Monophosphate, Alkaline… 1
- JGJ Photometric Method, Magnesium 1
- LFQ Acid, Uric, Acid Reduction Of Ferric Ion 1
- CGS Nad Reduction/Nadh Oxidation, Cpk Or… 1
- CIC Cresolphthalein Complexone, Calcium 1
- CDL Berthelot Indophenol, Urea Nitrogen 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
| K861713 | Serum Potassium Reagent SetCEJ · Traditional | 05/23/1986SE |
| K861615 | Salicylate Reagent SetDKJ · Traditional | 05/23/1986SE |
| K861311 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 04/24/1986SE |
| K860350 | Serum Cholinesterase Reagent SetDLI · Traditional | 04/24/1986SE |
| K860667 | Aspartate Aminotransferase (Ast/Sgot) Reagent SetCIT · Traditional | 04/03/1986SE |
| K860485 | SGPT (Alt) Reagent Set (Colorimetric)CKD · Traditional | 04/03/1986SE |
| K860477 | Uric Acid Reagnet Set (Trinder)KNK · Traditional | 04/03/1986SE |
| K860216 | Sgot (Ast) Reagent SetCIQ · Traditional | 04/03/1986SE |
| K860348 | Gamma Glutamyl Transpeptidase (GGTP) Reagent SetJPZ · Traditional | 03/17/1986SE |
| K860214 | Total Bilirubin Reagent SetCIG · Traditional | 03/17/1986SE |
| K860628 | Inorganic Phosphorus Reagent SetCEO · Traditional | 03/14/1986SE |
| K860554 | Serum Lipase Reagent Set (Turbidimetric)CFG · Traditional | 03/14/1986SE |
| K860478 | Serum Iron & Iron Binding Reagent SetJIY · Traditional | 03/14/1986SE |
| K860476 | Acid Phosphatase Reagent SetCKE · Traditional | 03/05/1986SE |
| K860475 | Hemoglobin Reagent SetKHG · Traditional | 03/03/1986SE |
| K860530 | Amylase Reagent Set (Modified Caraway)CJA · Traditional | 02/28/1986SE |
| K860349 | Lactate Dehydrogenase (LDH) Reagent SetCFH · Traditional | 02/28/1986SE |
| K860420 | Sickle Cell Reagent SetGHM · Traditional | 02/24/1986SE |
| K860340 | Serum Albumin (BCG) Reagent SetCIX · Traditional | 02/19/1986SE |
| K855164 | Enzynatic Triglycerides Reagent SetCDT · Traditional | 02/19/1986SE |
| K860419 | Urea Nitrogen Reagent SetCDW · Traditional | 02/11/1986SE |
| K860418 | Creatinine Reagent SetCGX · Traditional | 02/11/1986SE |
| K860351 | Alkaline Phosphatase Reagent SetCIO · Traditional | 02/11/1986SE |
| K860341 | Total Protein (Biuret) Reagent SetCEK · Traditional | 02/11/1986SE |
| K860215 | Magnesium Reagent SetJGJ · Traditional | 02/11/1986SE |
| K860142 | Uric Acid Reagent Set (Colorimetric)LFQ · Traditional | 02/11/1986SE |
| K860096 | CPK Reagent Set (Colorimetric)CGS · Traditional | 02/11/1986SE |
| K860044 | Calcium (CPC) Reagent SetCIC · Traditional | 02/11/1986SE |
| K860154 | Bun (Enzymatic Berthelot) Reagent SetCDL · Traditional | 02/06/1986SE |
| K855028 | Total Cholesterol Reagent SetCHH · Traditional | 01/28/1986SE |
| K854335 | Glucose Reagent Set (God/Trinder)CGA · Traditional | 11/22/1985SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0937-2017 Class III | Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0936-2017 Class III | Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0935-2017 Class III | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0934-2017 Class III | Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0933-2017 Class III | Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0932-2017 Class III | Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0931-2017 Class III | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0930-2017 Class III | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |
| Z-0929-2017 Class III | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative…Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of… | 07/20/2016Terminated |