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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 K914486
Device Name COULTER CARBON DIOXIDE REAGENT
Applicant
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Applicant Contact JIM HOSKINSON
Correspondent
Coulter Corp.
600 Coulter Way
Hialeah,  FL  33010
Correspondent Contact JIM HOSKINSON
Regulation Number862.1160
Classification Product Code
KHS  
Date Received10/08/1991
Decision Date 11/27/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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