fda 510k approval, page-2

Hi Brown,

The requirement is to be broadly equivalent to devices made before 1978 - not current market devices.

Immuno-assay devices have been around for a long time - the chemical process that urine based devices use, so equivalency should not be an issue with the right information submitted. Sun needed to go through the process as a slap on the wrist for failing to submit paperwork properly as per the April letter from the FDA.