Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K020662
Device Classification Name
Immunoassay Method, Troponin Subunit
More FDA Info for this Device
510(K) Number
K020662
Device Name
Immunoassay Method, Troponin Subunit
Applicant
ORTHO-CLINICAL DIAGNOSTICS
100 INDIGO CREEK DR.
ROCHESTER, NY 14626-5101 US
Other 510(k) Applications for this Company
Contact
ANN M QUINN
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
03/01/2002
Decision Date
04/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact