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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cresolphthalein Complexone, Calcium
510(k) Number K881054
Device Name CALCIUM, CATALOGUE NUMBER 122-20
Applicant
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Applicant Contact CALLBECK, R.T.
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
16 First St.
West Royalty Industrial Park
Charlottestown,Pei,Canada,  CA C1E 1B0
Correspondent Contact CALLBECK, R.T.
Regulation Number862.1145
Classification Product Code
CIC  
Date Received03/11/1988
Decision Date 04/18/1988
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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