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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name needle, aspiration and injection, disposable
510(k) Number K011586
Device Name IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
Applicant
DIAMETRICS MEDICAL, INC.
2658 PATTON RD.
SAINT PAUL,  MN  55113
Applicant Contact NANCY RING
Correspondent
DIAMETRICS MEDICAL, INC.
2658 PATTON RD.
SAINT PAUL,  MN  55113
Correspondent Contact NANCY RING
Regulation Number878.4800
Classification Product Code
GAA  
Subsequent Product Code
JGS  
Date Received05/23/2001
Decision Date 11/16/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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