Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K033780
Device Classification Name
Antibody Igm, If, Epstein-Barr Virus
More FDA Info for this Device
510(K) Number
K033780
Device Name
Antibody Igm, If, Epstein-Barr Virus
Applicant
QUEST INTL., INC.
1938 N.E. 148TH TERR.
NORTH MIAMI, FL 33181 US
Other 510(k) Applications for this Company
Contact
ROBERT A CORT
Other 510(k) Applications for this Contact
Regulation Number
866.3235
More FDA Info for this Regulation Number
Classification Product Code
LJN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2003
Decision Date
01/15/2004
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact