Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K954840
Device Classification Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K954840
Device Name
Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
SIGMA DIAGNOSTICS, INC.
545 SOUTH EWING AVE.
ST. LOUIS, MO 63103 US
Other 510(k) Applications for this Company
Contact
WILLIAM R GILBERT
Other 510(k) Applications for this Contact
Regulation Number
862.1050
More FDA Info for this Regulation Number
Classification Product Code
CJE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/20/1995
Decision Date
02/28/1996
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