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FDA 510(k)

REMEL SPECTRA VRE

K-Number: K092819 · 2010-07-15

ApplicantThermo Fisher Scientific
Decision Date2010-07-15
Product CodeJSO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

REMEL SPECTRA VRE 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 2010-07-15 under 510(k) number K092819. 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 REMEL SPECTRA VRE?

REMEL SPECTRA VRE is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Thermo Fisher Scientific. The 510(k) number is K092819.

When did REMEL SPECTRA VRE receive FDA 510(k) clearance?

REMEL SPECTRA VRE received FDA 510(k) clearance on 2010-07-15, under 510(k) number K092819.

Who is the listed applicant for REMEL SPECTRA VRE?

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 REMEL SPECTRA VRE?

The FDA product code for REMEL SPECTRA VRE 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.

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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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