Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971585
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
More FDA Info for this Device
510(K) Number
K971585
Device Name
Enzyme Linked Immunoabsorbent Assay, Rotavirus
Applicant
MERIDIAN DIAGNOSTICS, INC.
3471 RIVER HILLS DR.
CINCINNATI, OH 45244 US
Other 510(k) Applications for this Company
Contact
ALLEN D NICKOL
Other 510(k) Applications for this Contact
Regulation Number
866.3405
More FDA Info for this Regulation Number
Classification Product Code
LIQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/01/1997
Decision Date
08/20/1997
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact