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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K853405
Device Name ELECTROLYTE ANALYZER SERA-252
Applicant
HORIBA INSTRUMENTS, INC.
1021 DURYEA AVE.
IRVINE,  CA  92714
Applicant Contact TIM SCOTT
Correspondent
HORIBA INSTRUMENTS, INC.
1021 DURYEA AVE.
IRVINE,  CA  92714
Correspondent Contact TIM SCOTT
Regulation Number862.1120
Classification Product Code
CHL  
Date Received08/12/1985
Decision Date 12/04/1985
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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