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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K964829
Device Name ELECSYS CALCHECK FSH
Applicant
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
CONCORD,  CA  94524
Applicant Contact Yvette Lloyd
Correspondent
BOEHRINGER MANNHEIM CORP.
2400 BISSO LN.
CONCORD,  CA  94524
Correspondent Contact Yvette Lloyd
Regulation Number862.1150
Classification Product Code
JIX  
Date Received12/02/1996
Decision Date 12/16/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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