510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Ams Diagnostics

Weston, FL, US

Ams Diagnostics appears in FDA device records in Weston, FL. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of , FDA records show 4 recalls for this company.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
4
Registered establishments
0

510(k) clearance history

FDA records hold 1 510(k) clearance for Ams Diagnostics in 2019.

Clearances by year, as a table
510(k) clearance decisions for Ams Diagnostics, by decision year
YearClearances
20191
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K172232LIASYS 600 Electrolyte Measurement System, LIASYS 600 Creatinine reagent, LIASYS 600JGSSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2725-2017Medica 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 system analysis.Lot was not functioning properly and not exhibiting the correct physical properties.Class IIIOpen, Classified
Z-1269-2014AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.Marketing the devices outside 510(k) requirementsClass IITerminated
Z-1268-2014AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.Marketing the devices outside 510(k) requirementsClass IITerminated
Z-1267-2014AMS BUN UREA NITROGEN For the In vitro quantitative determination of Urea Nitrogen in serum Quantitative determination of Bun in serum.Marketing the devices outside 510(k) requirementsClass IITerminated

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Data as of , FDA export datePage updated Source: openFDA, public domain