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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 (Photometric, Discrete), For Clinical Use
510(k) Number K883539
Device Name SR1 SYSTEM AUTOMATED PHOTOMETRIC ANALYZER
Applicant
Serono-Baker Diagnostics, Inc.
P.O. Box 2867
3085 Shawnee Dr.
Winchester,  VA  22601
Applicant Contact RICHARD TOMALESKY
Correspondent
Serono-Baker Diagnostics, Inc.
P.O. Box 2867
3085 Shawnee Dr.
Winchester,  VA  22601
Correspondent Contact RICHARD TOMALESKY
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/16/1988
Decision Date 10/31/1988
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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