Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K013925
Device Classification Name
Manual Antimicrobial Susceptibility Test Systems
More FDA Info for this Device
510(K) Number
K013925
Device Name
Manual Antimicrobial Susceptibility Test Systems
Applicant
TREK DIAGNOSTIC SYSTEMS, INC.
29299 CLEMENS RD., SUITE 1-K
WESTLAKE, OH 44145 US
Other 510(k) Applications for this Company
Contact
CYNTHIA C KNAPP
Other 510(k) Applications for this Contact
Regulation Number
866.1640
More FDA Info for this Regulation Number
Classification Product Code
JWY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/14/2001
Decision Date
12/21/2001
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact