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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion specific, urea nitrogen
510(k) Number K800616
Device Name BUN REAGENT KIT #88108
Applicant
HI CHEM, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
HI CHEM, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.1770
Classification Product Code
CDS  
Date Received03/18/1980
Decision Date 04/10/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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