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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name controls for blood-gases, (assayed and unassayed)
510(k) Number K855024
Device Name MARQUEST QC-IV TONOMETER
Applicant
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Applicant Contact ROBERT J MCKINNON
Correspondent
MARQUEST MEDICAL PRODUCTS, INC.
11039 EAST LANSING CIR.
ENGLEWOOD,  CO  80112
Correspondent Contact ROBERT J MCKINNON
Regulation Number862.1660
Classification Product Code
JJS  
Date Received12/17/1985
Decision Date 04/07/1986
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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