Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070640
Device Classification Name
Immunoassay Method, Troponin Subunit
More FDA Info for this Device
510(K) Number
K070640
Device Name
Immunoassay Method, Troponin Subunit
Applicant
FISHER DIAGNOSTICS
8365 VALLEY PIKE, PO BX 307
MIDDLETOWN, VA 22645 US
Other 510(k) Applications for this Company
Contact
HEATHER CAMERON
Other 510(k) Applications for this Contact
Regulation Number
862.1215
More FDA Info for this Regulation Number
Classification Product Code
MMI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/07/2007
Decision Date
09/13/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact