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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 K010864
Device Name ANALYST PANELS + ANALYTICAL TEST ROTOR
Applicant
Hemagen Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact JOSE A MONTANEZ
Correspondent
Hemagen Diagnostics, Inc.
9033 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact JOSE A MONTANEZ
Regulation Number862.1160
Classification Product Code
KHS  
Subsequent Product Codes
CEO   CIG   CIX  
Date Received03/22/2001
Decision Date 05/21/2001
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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