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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 the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2017-12-28 under 510(k) 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. The listed applicant is Bio-Rad. The 510(k) number is K171061.

When did MRSASelect II receive FDA 510(k) clearance?

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

Who is the listed applicant for MRSASelect II?

The FDA 510(k) record lists Bio-Rad as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MRSASelect II?

The FDA product code for MRSASelect II is JSO.

Related Devices (Code: JSO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190553HardyCHROM CREHardy DiagnosticsK181092CHROMID CARBA agar (CARB)Biomerieux S.A.K162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID MRSAbioMerieux, Inc.K151688chromID MRSAbioMerieux, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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