Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K963383
Device Classification Name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
More FDA Info for this Device
510(K) Number
K963383
Device Name
Phenylphosphate, Alkaline Phosphatase Or Isoenzymes
Applicant
HICHEM DIAGNOSTICS
231 NORTH PUENTE ST.
BREA, CA 92821 US
Other 510(k) Applications for this Company
Contact
WYNN STOCKING
Other 510(k) Applications for this Contact
Regulation Number
862.1050
More FDA Info for this Regulation Number
Classification Product Code
CKF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/27/1996
Decision Date
09/23/1996
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