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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 K830181
Device Name REFEREE BLOOD GAS ANALYZER CONTROLS
Applicant
Analytical Products, Inc.
511 Taylor Way
Belmont,  CA  94002
Applicant Contact RONALD SMERNOFF
Correspondent
Analytical Products, Inc.
511 Taylor Way
Belmont,  CA  94002
Correspondent Contact RONALD SMERNOFF
Regulation Number862.1660
Classification Product Code
JJS  
Date Received01/18/1983
Decision Date 02/28/1983
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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