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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cresolphthalein Complexone, Calcium
510(k) Number K844243
Device Name TOTAL BILIRUBIN FOR DEMAND ANALYZER
Applicant
Advanced Biomedical Methods, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Applicant Contact JACK M GOLDBERG
Correspondent
Advanced Biomedical Methods, Inc.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent Contact JACK M GOLDBERG
Regulation Number862.1145
Classification Product Code
CIC  
Date Received11/01/1984
Decision Date 01/03/1985
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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