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FDA 510(k)

MRSASelect II

K-Number: K171061 · 2017-12-28

ApplicantBio-Rad
Decision Date2017-12-28
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MRSASelect II is a medical device manufactured by Bio-Rad. It received FDA 510(k) clearance on 2017-12-28 under approval number K171061. The device is classified under product code JSO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRSASelect II?

MRSASelect II is a medical device that received FDA 510(k) clearance on 2017-12-28. It is manufactured by Bio-Rad. The 510(k) number is K171061.

When was MRSASelect II approved by the FDA?

MRSASelect II received FDA 510(k) clearance on 2017-12-28, under approval number K171061.

What company makes MRSASelect II?

MRSASelect II is manufactured by Bio-Rad.

What is the FDA product code for MRSASelect II?

The FDA product code for MRSASelect II is JSO.

Related Devices (Code: JSO)

Official Source

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