Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973448
Device Classification Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
More FDA Info for this Device
510(K) Number
K973448
Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant
BECKMAN INSTRUMENTS, INC.
1000 LAKE HAZELTINE DR.
CHASKA, MN 55318-1084 US
Other 510(k) Applications for this Company
Contact
MICHELE BURTNESS
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
09/11/1997
Decision Date
09/17/1998
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