Company ยท US
AMS Diagnostics, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2019. Name variants (Inc, Corp, punctuation) are merged.
1510(k) clearances (0 in 12 months)
4recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 29, 2016 | AMS Diagnostics, LLC Medica ISE Module Calibrant A; 500 mL - 140 mmol/L Na+, 125 mmol/L Cl-, buffers and preservatives; For use with ISE Module;
Product Usage:
Calibrations of ISE Model for integrated electrolyte sys Open, Classified |
JIX | None listed |
| Mar 21, 2014 | AMS Diagnostics, LLC AMS AST For the In vitro quantitative determination of AST in serum
Quantitative determination of AST in serum. Terminated |
NJT | None listed |
| Mar 21, 2014 | AMS Diagnostics, LLC AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum
Quantitative determination of Uric Acid in serum. Terminated |
NJT | None listed |
| Mar 21, 2014 | AMS Diagnostics, LLC AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum
Quantitative determination of Bun in serum. Terminated |
NJT | None listed |