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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 K772192
Device Name NEONATAL TSH RIA KIT (125I)
Applicant
DIAGNOSTIC PRODUCTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
DIAGNOSTIC PRODUCTS CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1690
Classification Product Code
JLW  
Date Received11/25/1977
Decision Date 01/12/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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