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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 K880866
Device Name CARBON DIOXIDE ASSAY KIT(ENZY. SINGLE) 203-10
Applicant
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Applicant Contact DAVID TEMPLETON
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Correspondent Contact DAVID TEMPLETON
Regulation Number862.1160
Classification Product Code
KHS  
Date Received03/01/1988
Decision Date 04/28/1988
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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