Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191099
Device Classification Name
Enzyme Immunoassay, Amphetamine
More FDA Info for this Device
510(K) Number
K191099
Device Name
Enzyme Immunoassay, Amphetamine
Applicant
Atlas Medical
King Abdullah Industrial Estate, Sahab free zone Area
P.O Box 204
Amman JO
Other 510(k) Applications for this Company
Contact
Amani AL-Habahbeh
Other 510(k) Applications for this Contact
Regulation Number
862.3100
More FDA Info for this Regulation Number
Classification Product Code
DKZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/25/2019
Decision Date
10/03/2019
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