Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K022108
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K022108
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
THERMO DMA, INC.
845 AVE. G EAST
ARLINGTON, TX 76011 US
Other 510(k) Applications for this Company
Contact
THOMAS DOLLAR
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/2002
Decision Date
07/25/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact