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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas Chromatograph, Carbon-Monoxide
510(k) Number K830843
Device Name BLOOD GAS SOLUTIONS & CO-OXIMETER SOLU-
Applicant
Rna Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Rna Medical Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3220
Classification Product Code
JKT  
Date Received03/17/1983
Decision Date 04/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
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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