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
|
|
Correspondent Contact |
Lingjun Chen |
Regulation Number | 866.3980
|
Classification Product Code |
|
Subsequent Product Code |
|
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
|
Recalls |
CDRH Recalls
|
|
|