Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K955102
Device Classification Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
More FDA Info for this Device
510(K) Number
K955102
Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant
BIOCHEM IMMUNOSYSTEMS (U.S.), INC.
100 CASCADE DR.
ALLENTOWN, PA 18103-9562 US
Other 510(k) Applications for this Company
Contact
LAURENCE A POTTER
Other 510(k) Applications for this Contact
Regulation Number
862.1680
More FDA Info for this Regulation Number
Classification Product Code
CDZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/1995
Decision Date
06/24/1996
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