Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K983468
Device Classification Name
Calculator/Data Processing Module, For Clinical Use
More FDA Info for this Device
510(K) Number
K983468
Device Name
Calculator/Data Processing Module, For Clinical Use
Applicant
SELFCARE, INC.
200 PROSPECT ST.
WALTHAM, MA 02154-3457 US
Other 510(k) Applications for this Company
Contact
BETTY LANE
Other 510(k) Applications for this Contact
Regulation Number
862.2100
More FDA Info for this Regulation Number
Classification Product Code
JQP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/1998
Decision Date
12/17/1998
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