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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 K883350
Device Name RECONDITIONED ASTRA(TM) 4
Applicant
Associated Electro-Medical Services, Inc.
P.O. Box 1260
Matthews,  NC  28106
Applicant Contact WALTER J GILMORE,JR
Correspondent
Associated Electro-Medical Services, Inc.
P.O. Box 1260
Matthews,  NC  28106
Correspondent Contact WALTER J GILMORE,JR
Regulation Number862.2170
Classification Product Code
JJF  
Date Received08/09/1988
Decision Date 03/16/1989
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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