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510(k) K072631

JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123 by Idaho Technology, Inc. — Product Code NHT

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 20, 2007
Date Received: September 18, 2007
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Assay, Nucleic Acid Amplification, Bacillus Anthracis
Device Class: Class II
Regulation Number: 866.3045
Review Panel: MI
Submission Type

An invitro diagnostic device used to presumptively detect the presence or absence of b. Anthracis directly in blood specimens or suspicious culture growth.

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K072547 — JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124 (December 19, 2007)
K071188 — MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEM (May 21, 2007)
K051713 — JBAIDS ANTHRAC DETECTION SYSTEM (November 18, 2005)