Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K010138
Device Classification Name
Enzyme Immunoassay, Cannabinoids
More FDA Info for this Device
510(K) Number
K010138
Device Name
Enzyme Immunoassay, Cannabinoids
Applicant
MEDTOX DIAGNOSTICS, INC.
1238 ANTHONY RD.
BURLINGTON, NC 27215 US
Other 510(k) Applications for this Company
Contact
MICHAEL TURANCHIK
Other 510(k) Applications for this Contact
Regulation Number
862.3870
More FDA Info for this Regulation Number
Classification Product Code
LDJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/17/2001
Decision Date
02/14/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
TX - Clinical Toxicology
Review Advisory Committee
TX - Clinical Toxicology
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact