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FDA 510(k)

FILMARRAY RP PANEL

K-Number: K120267 · 2012-05-15

ApplicantIdaho Technology, Inc.
Decision Date2012-05-15
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

FILMARRAY RP PANEL is the device name listed in this FDA 510(k) record. The listed applicant is Idaho Technology, Inc.. It received FDA 510(k) clearance on 2012-05-15 under 510(k) number K120267. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILMARRAY RP PANEL?

FILMARRAY RP PANEL is a medical device that received FDA 510(k) clearance on 2012-05-15. The listed applicant is Idaho Technology, Inc.. The 510(k) number is K120267.

When did FILMARRAY RP PANEL receive FDA 510(k) clearance?

FILMARRAY RP PANEL received FDA 510(k) clearance on 2012-05-15, under 510(k) number K120267.

Who is the listed applicant for FILMARRAY RP PANEL?

The FDA 510(k) record lists Idaho Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FILMARRAY RP PANEL?

The FDA product code for FILMARRAY RP PANEL is OCC.

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Other records listing Idaho Technology, Inc. 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.

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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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