Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K992720
Device Classification Name
Enzyme Immunoassay, Benzodiazipine
More FDA Info for this Device
510(K) Number
K992720
Device Name
Enzyme Immunoassay, Benzodiazipine
Applicant
AMERICAN BIO MEDICA CORP.
1001 G STREET, NW
SUITE 500W
WASHINGTON, DC 20001 US
Other 510(k) Applications for this Company
Contact
JOHN B DUBECK
Other 510(k) Applications for this Contact
Regulation Number
862.3170
More FDA Info for this Regulation Number
Classification Product Code
JXM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/13/1999
Decision Date
04/03/2000
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