Sterling Diagnostics, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 9
- 510(k) Clearances
- 41
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0936-2017 | Class III | Urea Nitrogen/Color BUN (Enzymatic Berthelot) for IN VITRO DIAGNOSTIC USE in the quantitative determ | July 20, 2016 |
| Z-0934-2017 | Class III | Sterling Diagnostics, Inc.Colorimetric SGOT for IN VITRO DIAGNOSTIC USE in the quantitative determin | July 20, 2016 |
| Z-0932-2017 | Class III | Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative deter | July 20, 2016 |
| Z-0931-2017 | Class III | Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the quantitative | July 20, 2016 |
| Z-0935-2017 | Class III | Sterling Diagnostics, Inc., SGPT Colorimetric for IN VITRO DIAGNOSTIC USE in the quantitative determ | July 20, 2016 |
| Z-0937-2017 | Class III | Sterling Diagnostics, Inc., Enzymatic Uric Acid (Uricase Trinder) for IN VITRO DIAGNOSTIC USE in the | July 20, 2016 |
| Z-0930-2017 | Class III | Sterling Diagnostics, Inc., HDL Cholesterol (PEF Method) for IN VITRO DIAGNOSTIC USE in the quantita | July 20, 2016 |
| Z-0933-2017 | Class III | Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantita | July 20, 2016 |
| Z-0929-2017 | Class III | Enzymatic Cholesterol (Trinder/COD-CEH) for IN VITRO DIAGNOSTIC USE in the quantitative determinatio | July 20, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K921412 | MICROPROTEIN REAGENT SET | January 21, 1993 |
| K914609 | TRIGLYCERIDES REAGENT SET | November 7, 1991 |
| K914039 | SODIUM REAGENT SET | October 31, 1991 |
| K914040 | PHOSPHOLIPID REAGENT SET | October 30, 1991 |
| K862255 | LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE) | July 29, 1986 |
| K861962 | VANILMANDELIC ACID (VMA) REAGENT SET | July 7, 1986 |
| K862256 | ALKALINE PHOSPHATASE (PNPP RATE) REAGENT SET | July 1, 1986 |
| K862210 | UREA NITROGEN (GLDH) REAGENT SET (UV) | July 1, 1986 |
| K862209 | ALT (SGPT) REAGENT SET (UV RATE) | June 25, 1986 |
| K861855 | HYDROXYBUTYRATE DEHYDROGENASE (HBD) REAGENT SET | June 16, 1986 |
| K861713 | SERUM POTASSIUM REAGENT SET | May 23, 1986 |
| K861615 | SALICYLATE REAGENT SET | May 23, 1986 |
| K860350 | SERUM CHOLINESTERASE REAGENT SET | April 24, 1986 |
| K861311 | GLUCOSE (HEXOKINASE) REAGENT SET | April 24, 1986 |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | April 3, 1986 |
| K860477 | URIC ACID REAGNET SET (TRINDER) | April 3, 1986 |
| K860667 | ASPARTATE AMINOTRANSFERASE (AST/SGOT) REAGENT SET | April 3, 1986 |
| K860216 | SGOT (AST) REAGENT SET | April 3, 1986 |
| K860214 | TOTAL BILIRUBIN REAGENT SET | March 17, 1986 |
| K860348 | GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET | March 17, 1986 |