Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K971522
Device Classification Name
Antisera, All Groups, Streptococcus Spp.
More FDA Info for this Device
510(K) Number
K971522
Device Name
Antisera, All Groups, Streptococcus Spp.
Applicant
ABBOTT LABORATORIES
200 ABBOTT PARK RD.
ABBOTT PARK, IL 60064 US
Other 510(k) Applications for this Company
Contact
GRACE LEMIEUX
Other 510(k) Applications for this Contact
Regulation Number
866.3740
More FDA Info for this Regulation Number
Classification Product Code
GTZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/1997
Decision Date
03/03/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact