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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 K910256
Device Name ECLIPSE ICA TSH
Applicant
Biotope, Inc.
12277 134th Ct., NE
Redmond,  WA  98052
Applicant Contact LYNN SHANTA
Correspondent
Biotope, Inc.
12277 134th Ct., NE
Redmond,  WA  98052
Correspondent Contact LYNN SHANTA
Regulation Number862.1690
Classification Product Code
JLW  
Date Received01/22/1991
Decision Date 02/22/1991
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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