Hi all,
1. For an IVD instrument(has software with it), which has got 510(k) clearance, if the service pack (SP)-2 is changed or upgraded to SP-3 of Microsoft Windows OS, then do we need to submit supplementary 510() for this change?
2. For a 510(k) cleared instrument label, what are the implications for a lable change? The label change includes adding CE symbol, IVD symbol.
Thanks,
Sreenu
1. For an IVD instrument(has software with it), which has got 510(k) clearance, if the service pack (SP)-2 is changed or upgraded to SP-3 of Microsoft Windows OS, then do we need to submit supplementary 510() for this change?
2. For a 510(k) cleared instrument label, what are the implications for a lable change? The label change includes adding CE symbol, IVD symbol.
Thanks,
Sreenu