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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 K843680
Device Name URI-VAL
Applicant
Cenogenics Corp.
620 Rte. 520
Morganville,  NJ  07751
Applicant Contact MICHAEL KATZ
Correspondent
Cenogenics Corp.
620 Rte. 520
Morganville,  NJ  07751
Correspondent Contact MICHAEL KATZ
Regulation Number862.1540
Classification Product Code
JMZ  
Date Received09/18/1984
Decision Date 03/29/1985
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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