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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cresol Red Colorimetry, Carbon-Dioxide
510(k) Number K833724
Device Name ENZYMATIC CO2
Applicant
American Monitor Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
American Monitor Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1160
Classification Product Code
CIL  
Date Received10/24/1983
Decision Date 12/29/1983
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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