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FDA 510(k)

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT

K-Number: K113433 · 2012-04-04

ApplicantFocus Diagnostics, Inc.
Decision Date2012-04-04
Product CodeOMN
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT is the device name listed in this FDA 510(k) record. The listed applicant is Focus Diagnostics, Inc.. It received FDA 510(k) clearance on 2012-04-04 under 510(k) number K113433. The device is classified under product code OMN. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT?

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT is a medical device that received FDA 510(k) clearance on 2012-04-04. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K113433.

When did SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT receive FDA 510(k) clearance?

SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT received FDA 510(k) clearance on 2012-04-04, under 510(k) number K113433.

Who is the listed applicant for SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT?

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

What is the FDA product code for SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT?

The FDA product code for SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT is OMN.

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Other records listing Focus Diagnostics, 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.

K120986STRATIFY JCV DXSELECTK120413SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACKK102170SIMPLEXA FLU A/B & RSVK1023143M INTEGRATED CYCLER (110V) & (220V)K100148SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500K073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M

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Related Devices (Code: OMN)

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.

K110203XPERT C. DIFFICLE/EPI ASSAYCepheidK110012ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10Meridian Bioscience, Inc.K100818ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920Meridian Bioscience, 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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