LIAT STREP A ASSAY


Device Classification Name

groups a, c and g beta-hemolytic streptococcus nucleic acid amplification system

510(k) Number K141338
Device Name LIAT STREP A ASSAY
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 866.2680
Classification Product Code
PGX  
Date Received 05/21/2014
Decision Date 11/04/2014
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