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FDA 510(k) Application Details - K141338
Device Classification Name
More FDA Info for this Device
510(K) Number
K141338
Device Name
LIAT STREP A ASSAY
Applicant
IQUUM INC
700 NICKERSON ROAD
MARLBOROUGH, MA 01762-4663 US
Other 510(k) Applications for this Company
Contact
Lingjun Chen
Other 510(k) Applications for this Contact
Regulation Number
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Classification Product Code
PGX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/21/2014
Decision Date
11/04/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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