Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961354
Device Classification Name
Controls For Blood-Gases, (Assayed And Unassayed)
More FDA Info for this Device
510(K) Number
K961354
Device Name
Controls For Blood-Gases, (Assayed And Unassayed)
Applicant
RADIOMETER AMERICA, INC.
811 SHARON DR.
WESTLAKE, OH 44145-1598 US
Other 510(k) Applications for this Company
Contact
DONALD L BAKER
Other 510(k) Applications for this Contact
Regulation Number
862.1660
More FDA Info for this Regulation Number
Classification Product Code
JJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/08/1996
Decision Date
06/14/1996
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