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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Azo Dye, Calcium
510(k) Number K895873
Device Name CALCIUM, CATALOGUE NUMBER140-20
Applicant
Diagnostic Chemicals, Ltd. (Usa)
160 Christian St.
Oxford,  CT  06478
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
160 Christian St.
Oxford,  CT  06478
Correspondent Contact KAREN CALLBECK
Regulation Number862.1145
Classification Product Code
CJY  
Date Received10/04/1989
Decision Date 12/12/1989
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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