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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K844047
Device Name FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS
Applicant
Fisher Diagnostics
526 Rte. 303
Orangeburg,  NY  10962
Applicant Contact CHARLES B BREUER
Correspondent
Fisher Diagnostics
526 Rte. 303
Orangeburg,  NY  10962
Correspondent Contact CHARLES B BREUER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received10/17/1984
Decision Date 11/09/1984
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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