AMS Diagnostics, LLC
AMS Diagnostics, LLC appears in FDA public data with 4 recalls, 1 510(k) clearance, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2725-2017, Class III) was initiated on February 29, 2016. Its most recent 510(k) clearance was granted on June 12, 2019.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 1
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-2725-2017 | Class III | Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; F | February 29, 2016 |
| Z-1267-2014 | Class II | AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quant | February 11, 2014 |
| Z-1269-2014 | Class II | AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination o | February 11, 2014 |
| Z-1268-2014 | Class II | AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative dete | February 11, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K172232 | LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600 | June 12, 2019 |