Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K974810
Device Classification Name
Reagent, Borrelia Serological Reagent
More FDA Info for this Device
510(K) Number
K974810
Device Name
Reagent, Borrelia Serological Reagent
Applicant
BOSTON BIOMEDICA, INC.
375 WEST ST.
WEST BRIDGEWATER, MA 02379 US
Other 510(k) Applications for this Company
Contact
PATRICIA E GARRETT
Other 510(k) Applications for this Contact
Regulation Number
866.3830
More FDA Info for this Regulation Number
Classification Product Code
LSR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/23/1997
Decision Date
02/05/1998
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