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FDA 510(k)

JBAIDS INFLUENZA A&B DETECTION KIT

K-Number: K111775 · 2011-09-13

ApplicantU.S. Army Medical Material Development Acitvity
Decision Date2011-09-13
Product CodeOCC
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

JBAIDS INFLUENZA A&B DETECTION KIT is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Army Medical Material Development Acitvity. It received FDA 510(k) clearance on 2011-09-13 under 510(k) number K111775. 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 JBAIDS INFLUENZA A&B DETECTION KIT?

JBAIDS INFLUENZA A&B DETECTION KIT is a medical device that received FDA 510(k) clearance on 2011-09-13. The listed applicant is U.S. Army Medical Material Development Acitvity. The 510(k) number is K111775.

When did JBAIDS INFLUENZA A&B DETECTION KIT receive FDA 510(k) clearance?

JBAIDS INFLUENZA A&B DETECTION KIT received FDA 510(k) clearance on 2011-09-13, under 510(k) number K111775.

Who is the listed applicant for JBAIDS INFLUENZA A&B DETECTION KIT?

The FDA 510(k) record lists U.S. Army Medical Material Development Acitvity as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for JBAIDS INFLUENZA A&B DETECTION KIT?

The FDA product code for JBAIDS INFLUENZA A&B DETECTION KIT is OCC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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