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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 K883533
Device Name ABC FP ANALYZER
Applicant
Intl. Bioclinical, Inc.
Dba American Bioclinical
4432 SE 16th Ave.
Portland,  OR  97202
Applicant Contact JANELLE M BATLEY
Correspondent
Intl. Bioclinical, Inc.
Dba American Bioclinical
4432 SE 16th Ave.
Portland,  OR  97202
Correspondent Contact JANELLE M BATLEY
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/18/1988
Decision Date 12/15/1988
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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