Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K030044
Device Classification Name
C-Reactive Protein, Antigen, Antiserum, And Control
More FDA Info for this Device
510(K) Number
K030044
Device Name
C-Reactive Protein, Antigen, Antiserum, And Control
Applicant
REFERENCE DIAGNOSTICS, INC.
19 CROSBY DR. SUITE 30
BEDFORD, MA 01730 US
Other 510(k) Applications for this Company
Contact
JOSEPH LAWLOR
Other 510(k) Applications for this Contact
Regulation Number
866.5270
More FDA Info for this Regulation Number
Classification Product Code
DCK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/06/2003
Decision Date
09/30/2003
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
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