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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Visual, Pregnancy Hcg, Prescription Use
510(k) Number K920918
Device Name TMB CHROMOGEN/SUBSTRATE REAGENT SET
Applicant
Bio Clinic Co.
5977 Southwest Ave.
St. Louis,  MI  63139
Applicant Contact BRUCE F WATKINS
Correspondent
Bio Clinic Co.
5977 Southwest Ave.
St. Louis,  MI  63139
Correspondent Contact BRUCE F WATKINS
Regulation Number862.1155
Classification Product Code
JHI  
Date Received02/28/1992
Decision Date 04/07/1992
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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