Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K181305
Device Classification Name
Thin Layer Chromatography, Metamphetamine
More FDA Info for this Device
510(K) Number
K181305
Device Name
Thin Layer Chromatography, Metamphetamine
Applicant
Premier Biotech, Inc.
723 Kasota Avenue SE
Minneapolis, MN 55414 US
Other 510(k) Applications for this Company
Contact
Jacqueline Gale
Other 510(k) Applications for this Contact
Regulation Number
862.3610
More FDA Info for this Regulation Number
Classification Product Code
DJC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/17/2018
Decision Date
09/20/2018
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