LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER


Device Classification Name

respiratory virus panel nucleic acid assay system

510(k) Number K111387
Device Name LIAT (TM) INFLUENZA A / B ASSAY, LIAT (TM) ANALYZER
Applicant
IQUUM INC
700 nickerson road
marlborough, 
MA 
01762 -4663

Applicant Contact lingjun chen
Correspondent
IQUUM INC
700 nickerson road
marlborough, 
MA 
01762 -4663

Correspodent Contact lingjun chen
Regulation Number 866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received 05/17/2011
Decision Date 08/04/2011
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