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FDA 510(k)

MRSASELECT - EXTENDED INCUBATION

K-Number: K081212 · 2008-06-13

ApplicantBio-Rad
Decision Date2008-06-13
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MRSASELECT - EXTENDED INCUBATION is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Rad. It received FDA 510(k) clearance on 2008-06-13 under 510(k) number K081212. 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 - EXTENDED INCUBATION?

MRSASELECT - EXTENDED INCUBATION is a medical device that received FDA 510(k) clearance on 2008-06-13. The listed applicant is Bio-Rad. The 510(k) number is K081212.

When did MRSASELECT - EXTENDED INCUBATION receive FDA 510(k) clearance?

MRSASELECT - EXTENDED INCUBATION received FDA 510(k) clearance on 2008-06-13, under 510(k) number K081212.

Who is the listed applicant for MRSASELECT - EXTENDED INCUBATION?

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 - EXTENDED INCUBATION?

The FDA product code for MRSASELECT - EXTENDED INCUBATION 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 62793K100589MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENSK081362PLATELIA LYME IGM

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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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