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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K875207
Device Name ALBUMIN CAT. # 201-03
Applicant
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Applicant Contact KAREN CALLBECK
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
435 Main St.
Monroe,  CT  06468
Correspondent Contact KAREN CALLBECK
Regulation Number862.1035
Classification Product Code
CIX  
Date Received12/18/1987
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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