Day

January 29, 1996
29
Jan

Ionetics electrolyte analyzers (IVD)

January 29, 1996
Ionetics 1/29/96 electrolyte analyzers 1. Failure to ensure specification changes are subject to controls as stringent as those applied to the original specifications of the device [21 CFR 820.100(a)(2)]. For example, your firm failed to document and approve changes made to components and software for your electrolyte analyzers.
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