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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 K954825
Device Name ACCESS HYPERSENSITIVE TSH REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
Applicant
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact JAN OLSEN
Correspondent
Bio-Rad Laboratories, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact JAN OLSEN
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JIS  
Date Received10/20/1995
Decision Date 11/21/1995
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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