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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K010500
Device Name AUTOMATED WORKCELL CONTROL SOFTWARE
Applicant
LAB-INTERLINK, INC.
1011 SOUTH SADDLE CREEK RD.
OMAHA,  NE  68106
Applicant Contact DEBORAH S KIPP
Correspondent
LAB-INTERLINK, INC.
1011 SOUTH SADDLE CREEK RD.
OMAHA,  NE  68106
Correspondent Contact DEBORAH S KIPP
Regulation Number862.2160
Classification Product Code
JJE  
Subsequent Product Codes
GKP   GKZ   KHO  
Date Received02/21/2001
Decision Date 08/01/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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