FDA-Device2014-04-02Class II
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
AMS Diagnostics, LLC
Hazard
Marketing the devices outside 510(k) requirements
Sold states
Nationwide Distribution including FL, GA, MD, CA, NC, MA, SC, WY, and TX.
Affected count
116 kits
Manufactured in
1790 N Commerce Pkwy, N/A, Weston, FL, United States
Products
AMS AST For the In vitro quantitative determination of AST in serum Quantitative determination of AST in serum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1269-2014Don't want to check this manually?
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