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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
510(k) Number K965035
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM MICROALBUMIN (MA) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821
Applicant Contact ANNETTE HELLIE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821
Correspondent Contact ANNETTE HELLIE
Regulation Number862.1645
Classification Product Code
JIQ  
Date Received12/17/1996
Decision Date 04/17/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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