Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K981102
Device Classification Name
Myoglobin, Antigen, Antiserum, Control
More FDA Info for this Device
510(K) Number
K981102
Device Name
Myoglobin, Antigen, Antiserum, Control
Applicant
DADE BEHRING, INC.
PO BOX 6101
NEWARK, DE 19714-6101 US
Other 510(k) Applications for this Company
Contact
CAROLYN K GEORGE
Other 510(k) Applications for this Contact
Regulation Number
866.5680
More FDA Info for this Regulation Number
Classification Product Code
DDR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/1998
Decision Date
04/27/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
IM - Immunology
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact