Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K001086
Device Classification Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
More FDA Info for this Device
510(K) Number
K001086
Device Name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX 77598 US
Other 510(k) Applications for this Company
Contact
JOHN CLASS
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
04/04/2000
Decision Date
05/18/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
IM - Immunology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact