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FDA 510(k)

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS

K-Number: K100589 · 2010-10-29

ApplicantBio-Rad
Decision Date2010-10-29
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2010-10-29 under 510(k) number K100589. 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 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS?

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS is a medical device that received FDA 510(k) clearance on 2010-10-29. The listed applicant is Bio-Rad. The 510(k) number is K100589.

When did MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS receive FDA 510(k) clearance?

MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS received FDA 510(k) clearance on 2010-10-29, under 510(k) number K100589.

Who is the listed applicant for MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS?

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 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS?

The FDA product code for MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS is JSO.

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Other records listing Bio-Rad as applicant

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.

K171061MRSASelect IIK122187VRESELECT CULTURE MEDIUMK103684VRESELECT CULTURE MEDIUMK093678PLATELIA ASPERGILLUS EIA MODEL 62793K081362PLATELIA LYME IGMK081212MRSASELECT - EXTENDED INCUBATION

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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.K171061MRSASelect IIBio-RadK162620Remel Spectra ESBLRemel, Inc.K160512HardyCHROM ESBLHardy DiagnosticsK162076chromID 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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