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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Thyroid-Stimulating Hormone
510(k) Number K921958
Device Name ELISA TUBE TSH TEST
Applicant
Bio Clinic Co.
5977 Southwest Ave.
St. Louis,  MI  63139
Applicant Contact BRUCE G WATKINS
Correspondent
Bio Clinic Co.
5977 Southwest Ave.
St. Louis,  MI  63139
Correspondent Contact BRUCE G WATKINS
Regulation Number862.1690
Classification Product Code
JLW  
Date Received04/27/1992
Decision Date 07/02/1992
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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