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FDA 510(k)

MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM

K-Number: K071188 · 2007-05-21

ApplicantIdaho Technology, Inc.
Decision Date2007-05-21
Product CodeNHT
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Idaho Technology, Inc.. It received FDA 510(k) clearance on 2007-05-21 under 510(k) number K071188. The device is classified under product code NHT. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM?

MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-21. The listed applicant is Idaho Technology, Inc.. The 510(k) number is K071188.

When did MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM received FDA 510(k) clearance on 2007-05-21, under 510(k) number K071188.

Who is the listed applicant for MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM?

The FDA 510(k) record lists Idaho Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM?

The FDA product code for MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM is NHT.

Related Clinical Trials

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Other records listing Idaho Technology, 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.

K120267FILMARRAY RP PANELK103207JBAIDS Q FEVER DETECTION KITK110764FILMARRAY RP PANELK103175FILMARRAY RESPIRATORY PANEL (RP)K072631JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123K072547JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124

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Related Devices (Code: NHT)

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.

K192871B. anthracis Real-time PCR AssayCenters for Disease Control and PreventionK131930JBAIDS ANTHRAX DETECTION KITBiofire Diagnostics, Inc.K072631JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123Idaho Technology, Inc.K051713JBAIDS ANTHRAC DETECTION SYSTEMIdaho Technology, 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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