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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Comparison Of Freezing Points & Stds. Of Known Osmotic Pressure, Osmolality
510(k) Number K844589
Device Name OSMOLARITY STANDARDS
Applicant
Rna Medical Corp.
21 Cummings Park
Suite 228
Woburn,  MA  01801
Applicant Contact ADOLPH E D'AMICO
Correspondent
Rna Medical Corp.
21 Cummings Park
Suite 228
Woburn,  MA  01801
Correspondent Contact ADOLPH E D'AMICO
Regulation Number862.1540
Classification Product Code
JMZ  
Date Received11/26/1984
Decision Date 03/01/1985
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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