Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K121533
Device Classification Name
Urinary Homocystine (Nonquantitative) Test System
More FDA Info for this Device
510(K) Number
K121533
Device Name
Urinary Homocystine (Nonquantitative) Test System
Applicant
Tosoh BioScience, Inc.
6000 SHORELINE COURT
SUITE 101
SOUTH SAN FRANCISCO, CA 94080 US
Other 510(k) Applications for this Company
Contact
ROBERT WICK
Other 510(k) Applications for this Contact
Regulation Number
862.1377
More FDA Info for this Regulation Number
Classification Product Code
LPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/24/2012
Decision Date
06/15/2012
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