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Dear all:
Our company is preparing to submit 510(k) for the blood glucose monitor and the test strips, and when i search FDA's database, i find there are two ways to apply for 510(k), one is to apply for a blood glucose system, which includes the meter, the test strips, the control solutions and the lancet, the other way is to apply for the 510(k) for the meter, and apply for 510(k) for the test strips individually.
What is the difference between the 2 ways of 510(k) submission? Which one is benificary for the manufactuer?
Any response is appreciated.
Our company is preparing to submit 510(k) for the blood glucose monitor and the test strips, and when i search FDA's database, i find there are two ways to apply for 510(k), one is to apply for a blood glucose system, which includes the meter, the test strips, the control solutions and the lancet, the other way is to apply for the 510(k) for the meter, and apply for 510(k) for the test strips individually.
What is the difference between the 2 ways of 510(k) submission? Which one is benificary for the manufactuer?
Any response is appreciated.