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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 K912543
Device Name MICRO ALBUMIN EIA TEST KIT
Applicant
Immuno Diagnostic Center, Inc.
9978 Monroe Dr., Suite 303
Dallas,  TX  75220
Applicant Contact AMAL MUKHERJEE
Correspondent
Immuno Diagnostic Center, Inc.
9978 Monroe Dr., Suite 303
Dallas,  TX  75220
Correspondent Contact AMAL MUKHERJEE
Regulation Number862.1645
Classification Product Code
JIR  
Date Received06/10/1991
Decision Date 07/19/1991
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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