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FDA 510(k)

SPECTRA MRSA

K-Number: K073027 · 2008-02-28

ApplicantThermo Fisher Scientific
Decision Date2008-02-28
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPECTRA MRSA is the device name listed in this FDA 510(k) record. The listed applicant is Thermo Fisher Scientific. It received FDA 510(k) clearance on 2008-02-28 under 510(k) number K073027. 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 SPECTRA MRSA?

SPECTRA MRSA is a medical device that received FDA 510(k) clearance on 2008-02-28. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K073027.

When did SPECTRA MRSA receive FDA 510(k) clearance?

SPECTRA MRSA received FDA 510(k) clearance on 2008-02-28, under 510(k) number K073027.

Who is the listed applicant for SPECTRA MRSA?

The FDA 510(k) record lists Thermo Fisher Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRA MRSA?

The FDA product code for SPECTRA MRSA is JSO.

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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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