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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 K851120
Device Name DELFIA HTSH KIT
Applicant
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Applicant Contact ED ZIOR
Correspondent
Lkb Instruments, Inc.
9319 Gaither Rd.
Gaithersburg,  MD  20877
Correspondent Contact ED ZIOR
Regulation Number862.1690
Classification Product Code
JLW  
Date Received03/19/1985
Decision Date 05/31/1985
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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