Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K051925
Device Classification Name
Immunoassay Method, Troponin Subunit
More FDA Info for this Device
510(K) Number
K051925
Device Name
Immunoassay Method, Troponin Subunit
Applicant
ACCESS BIO INCORPORATE
2033 RT. 130 UNIT H
MONMOUTH JCT., NJ 08852 US
Other 510(k) Applications for this Company
Contact
YOUNG HO CHOI
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
07/18/2005
Decision Date
11/29/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact