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FDA 510(k)

SIMPLEXA FLU A/B & RSV

K-Number: K102170 · 2010-11-24

ApplicantFocus Diagnostics, Inc.
Decision Date2010-11-24
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SIMPLEXA FLU A/B & RSV 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 2010-11-24 under 510(k) number K102170. 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?

SIMPLEXA FLU A/B & RSV is a medical device that received FDA 510(k) clearance on 2010-11-24. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K102170.

When did SIMPLEXA FLU A/B & RSV receive FDA 510(k) clearance?

SIMPLEXA FLU A/B & RSV received FDA 510(k) clearance on 2010-11-24, under 510(k) number K102170.

Who is the listed applicant for SIMPLEXA FLU A/B & RSV?

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?

The FDA product code for SIMPLEXA FLU A/B & RSV is OCC.

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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 PACKK113433SIMPLEXA C. DIFFICILE UNIVERSAL DIRECTK1023143M 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: OCC)

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.

K262747ID NOW Influenza A & B 2; ID NOW RSV; ID NOW Strep A 2; ID NOW COVID-19 2.0Abbott Diagnostics Scarborough, Inc.K254139BioCode® Respiratory Pathogen Panel (RPP)Applied BioCode, Inc.K242613NxTAG® Respiratory Pathogen PanelLuminex Molecular Diagnostics, Inc.K232775ID NOW Influenza A & B 2Abbott Diagnostics Scarborough, Inc.K231017Panther Fusion AdV/hMPV/RV AssayHologic, Inc.K213822cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat SystemRoche Molecular Systems, 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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