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FDA 510(k)

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500

K-Number: K100148 · 2010-05-24

ApplicantFocus Diagnostics, Inc.
Decision Date2010-05-24
Product CodeOQW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 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 2010-05-24 under 510(k) number K100148. The device is classified under product code OQW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 is a medical device that received FDA 510(k) clearance on 2010-05-24. The listed applicant is Focus Diagnostics, Inc.. The 510(k) number is K100148.

When did SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 receive FDA 510(k) clearance?

SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 received FDA 510(k) clearance on 2010-05-24, under 510(k) number K100148.

Who is the listed applicant for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500?

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 INFLUENZA A H1N1 (2009) MODEL MOL2500?

The FDA product code for SIMPLEXA INFLUENZA A H1N1 (2009) MODEL MOL2500 is OQW.

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Related Devices (Code: OQW)

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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