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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 K841664
Device Name ENZYMATIC CO2 DIAGNOSTIC CHEMICAL
Applicant
Diagnostic Chemicals, Ltd. (Usa)
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1160
Classification Product Code
KHS  
Date Received04/23/1984
Decision Date 06/08/1984
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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