JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123


Device Classification Name

assay, nucleic acid amplification, bacillus anthracis

510(k) Number K072631
Device Name JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123
Applicant
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city, 
UT 
84108

Applicant Contact beth lingenfelter
Correspondent
IDAHO TECHNOLOGY, INC.
390 wakara way
salt lake city, 
UT 
84108

Correspodent Contact beth lingenfelter
Regulation Number 866.2660
Classification Product Code
NHT  
Date Received 09/18/2007
Decision Date 12/20/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No