FDA 510(k)

JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136

K-Number: K100287 · 2010-07-06

ApplicantU.S. Army Medical Material Development Command

Decision Date2010-07-06

Product CodeNXD

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 is the device name listed in this FDA 510(k) record. The listed applicant is U.S. Army Medical Material Development Command. It received FDA 510(k) clearance on 2010-07-06 under 510(k) number K100287. The device is classified under product code NXD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136?

JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 is a medical device that received FDA 510(k) clearance on 2010-07-06. The listed applicant is U.S. Army Medical Material Development Command. The 510(k) number is K100287.

When did JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 receive FDA 510(k) clearance?

JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 received FDA 510(k) clearance on 2010-07-06, under 510(k) number K100287.

Who is the listed applicant for JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136?

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

What is the FDA product code for JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136?

The FDA product code for JBAIDS INFLUENZA A/H5 DETECTION KIT, MODEL JRPD-ASY-0136 is NXD.

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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.