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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 K872305
Device Name IRMA-COUNT TSH RKTS1, RKTS2, RKTS5, RKTSX
Applicant
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Applicant Contact ASARCH, PHD
Correspondent
DIAGNOSTIC PRODUCTS CORP.
5700 WEST 96TH ST.
LOS ANGELES,  CA  90045 -5597
Correspondent Contact ASARCH, PHD
Regulation Number862.1690
Classification Product Code
JLW  
Date Received06/08/1987
Decision Date 07/01/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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