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FDA 510(k) Application Details - K093098
Device Classification Name
Automated Urinalysis System
More FDA Info for this Device
510(K) Number
K093098
Device Name
Automated Urinalysis System
Applicant
ARKRAY, INC.
1201 RICHARDSON DRIVE
SUITE 140
RICHARDSON, TX 75080 US
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Contact
KENNETH L BLOCK
Other 510(k) Applications for this Contact
Regulation Number
862.2900
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Classification Product Code
KQO
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/01/2009
Decision Date
12/23/2009
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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