Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K033479
Device Classification Name
Reagents, Clostridium Difficile Toxin
More FDA Info for this Device
510(K) Number
K033479
Device Name
Reagents, Clostridium Difficile Toxin
Applicant
REMEL INC
14000 UNITY STREET NW
RAMSEY, MN 55303 US
Other 510(k) Applications for this Company
Contact
DAVID TEICHER
Other 510(k) Applications for this Contact
Regulation Number
866.2660
More FDA Info for this Regulation Number
Classification Product Code
LLH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/03/2003
Decision Date
02/26/2004
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