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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 K901346
Device Name ES 300 IMMUNOASSAY SYSTEM
Applicant
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact CHERI EMMONS
Correspondent
BOEHRINGER MANNHEIM CORP.
9115 HAGUE RD.
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact CHERI EMMONS
Regulation Number862.2160
Classification Product Code
JJE  
Date Received03/23/1990
Decision Date 04/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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