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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K891544
Device Name DIALBUMIN
Applicant
Exocell, Inc.
3508 Market St., Suite 420
Philadelphia,  PA  19104
Applicant Contact COHEN, M.D.
Correspondent
Exocell, Inc.
3508 Market St., Suite 420
Philadelphia,  PA  19104
Correspondent Contact COHEN, M.D.
Regulation Number862.1645
Classification Product Code
JIR  
Date Received03/17/1989
Decision Date 06/09/1989
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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