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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 K810213
Device Name DAC-CEL TSH
Applicant
Burroughs Wellcome Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Burroughs Wellcome Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1690
Classification Product Code
JLW  
Date Received01/27/1981
Decision Date 02/10/1981
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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