FDA 510(k)

SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK

K-Number: K120413 · 2012-07-13

Decision Date2012-07-13

Product CodeOCC

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK 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 2012-07-13 under 510(k) number K120413. 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 SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK is a medical device that received FDA 510(k) clearance on 2012-07-13. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K120413.

When did SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK receive FDA 510(k) clearance?

SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK received FDA 510(k) clearance on 2012-07-13, under 510(k) number K120413.

Who is the listed applicant for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

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 FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK?

The FDA product code for SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK is OCC.

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Other records listing Focus Diagnostics, Inc. as applicant

K120986STRATIFY JCV DXSELECT K113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT K102170SIMPLEXA FLU A/B & RSV K1023143M INTEGRATED CYCLER (110V) & (220V)K100148SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 K073381PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M

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Related Devices (Code: OCC)

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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.