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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimeter, Photometer, Spectrophotometer For Clinical Use
510(k) Number K873583
Device Name AUTO-EIA
Applicant
Labsystems, Inc.
6200 W. Oakton
Morton Grove,  IL  60053
Applicant Contact NANCY SKOWRONSKI
Correspondent
Labsystems, Inc.
6200 W. Oakton
Morton Grove,  IL  60053
Correspondent Contact NANCY SKOWRONSKI
Regulation Number862.2300
Classification Product Code
JJQ  
Date Received09/03/1987
Decision Date 09/22/1987
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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