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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 K922273
Device Name ARRAY(R) 360
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Applicant Contact WILLIAM T RYAN
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd., W-337
Box 8000
Brea,  CA  92622
Correspondent Contact WILLIAM T RYAN
Regulation Number862.2700
Classification Product Code
JQX  
Date Received05/14/1992
Decision Date 08/19/1992
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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