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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Method, Creatinine
510(k) Number K030035
Device Name IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE
Applicant
Diametrics Medical, Inc.
2658 Patton Rd.
Roseville,  MN  55113
Applicant Contact NANCY RING
Correspondent
Diametrics Medical, Inc.
2658 Patton Rd.
Roseville,  MN  55113
Correspondent Contact NANCY RING
Regulation Number862.1225
Classification Product Code
JFY  
Date Received01/03/2003
Decision Date 06/25/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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