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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry, Micro, For Clinical Use
510(k) Number K781442
Device Name BECKMAN ASTRA SYSTEM
Applicant
Beckman Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Beckman Instruments, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2170
Classification Product Code
JJF  
Date Received08/23/1978
Decision Date 10/03/1978
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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