Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K061758
Device Classification Name
Radioimmunoassay, Angiotensin I And Renin
More FDA Info for this Device
510(K) Number
K061758
Device Name
Radioimmunoassay, Angiotensin I And Renin
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER, TX 77598 US
Other 510(k) Applications for this Company
Contact
SCOTT BISHOP
Other 510(k) Applications for this Contact
Regulation Number
862.1085
More FDA Info for this Regulation Number
Classification Product Code
CIB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/22/2006
Decision Date
07/28/2006
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact