Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K023317
Device Classification Name
Enzyme Immunoassay, Methadone
More FDA Info for this Device
510(K) Number
K023317
Device Name
Enzyme Immunoassay, Methadone
Applicant
Lin-Zhi International, Inc.
2391 ZANKER RD., SUITE 340
SAN JOSE, CA 95131-1124 US
Other 510(k) Applications for this Company
Contact
CHIU CHIN CHANG
Other 510(k) Applications for this Contact
Regulation Number
862.3620
More FDA Info for this Regulation Number
Classification Product Code
DJR
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/03/2002
Decision Date
12/12/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact