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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometer, For Clinical Use
510(k) Number K962294
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821 -6208
Applicant Contact SHERI HALL
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-337
Brea,  CA  92821 -6208
Correspondent Contact SHERI HALL
Regulation Number862.2700
Classification Product Code
JQX  
Subsequent Product Code
JJE  
Date Received06/14/1996
Decision Date 08/21/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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