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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K930679
Device Name DIRECT BILIRUBIN
Applicant
Horizon Diagnostics, Inc.
2195 Spring Arbor Rd.
Jackson,  MI  49203
Applicant Contact DAVID K GARCIA
Correspondent
Horizon Diagnostics, Inc.
2195 Spring Arbor Rd.
Jackson,  MI  49203
Correspondent Contact DAVID K GARCIA
Regulation Number862.1110
Classification Product Code
CIG  
Date Received02/09/1993
Decision Date 06/29/1993
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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