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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K001133
Device Name VITRO CHEMISTRY PRODUCTS ECO2 SLIDE & CALIBRATOR KIT 2
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Applicant Contact MARLENE SHULMAN
Correspondent
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Dr.
Rochester,  NY  14626
Correspondent Contact MARLENE SHULMAN
Regulation Number862.1160
Classification Product Code
KHS  
Subsequent Product Code
JIX  
Date Received04/10/2000
Decision Date 04/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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