Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971441
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
More FDA Info for this Device
510(K) Number
K971441
Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant
INOVA DIAGNOSTICS, INC.
10451 ROSELLE ST.
SAN DIEGO, CA 92121 US
Other 510(k) Applications for this Company
Contact
BRYS C MYERS
Other 510(k) Applications for this Contact
Regulation Number
866.3780
More FDA Info for this Regulation Number
Classification Product Code
LGD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/18/1997
Decision Date
12/02/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact