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FDA 510(k)

IMDX C.DIFFICILE FOR ABBOTT M2000

K-Number: K132235 · 2013-10-11

ApplicantIntelligent Medical Devices, Inc.
Decision Date2013-10-11
Product CodeOZN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMDX C.DIFFICILE FOR ABBOTT M2000 is the device name listed in this FDA 510(k) record. The listed applicant is Intelligent Medical Devices, Inc.. It received FDA 510(k) clearance on 2013-10-11 under 510(k) number K132235. The device is classified under product code OZN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMDX C.DIFFICILE FOR ABBOTT M2000?

IMDX C.DIFFICILE FOR ABBOTT M2000 is a medical device that received FDA 510(k) clearance on 2013-10-11. The listed applicant is Intelligent Medical Devices, Inc.. The 510(k) number is K132235.

When did IMDX C.DIFFICILE FOR ABBOTT M2000 receive FDA 510(k) clearance?

IMDX C.DIFFICILE FOR ABBOTT M2000 received FDA 510(k) clearance on 2013-10-11, under 510(k) number K132235.

Who is the listed applicant for IMDX C.DIFFICILE FOR ABBOTT M2000?

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

What is the FDA product code for IMDX C.DIFFICILE FOR ABBOTT M2000?

The FDA product code for IMDX C.DIFFICILE FOR ABBOTT M2000 is OZN.

Related Clinical Trials

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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Other records listing Intelligent Medical Devices, 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.

K131584IMDX FLU A/B AND RSV FOR ABBOTT M2000K123753IMDX VANR FOR ABBOTT M2000

Related Devices (Code: OZN)

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Official Source

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