Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K955630
Device Classification Name
Electrolyte Controls (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K955630
Device Name
Electrolyte Controls (Assayed And Unassayed)
Applicant
BIONOSTICS, INC.
2 CRAIG RD.
ACTON, MA 01720 US
Other 510(k) Applications for this Company
Contact
BRUCE R WILLIAMS
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/11/1995
Decision Date
03/01/1996
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact