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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 K942566
Device Name IMX ULTRASENSISTIVE HTSH II
Applicant
ABBOTT LABORATORIES
DEPT: 09V8 BLDG: AP5-2
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3500
Applicant Contact JOY C SONSALLA
Correspondent
ABBOTT LABORATORIES
DEPT: 09V8 BLDG: AP5-2
100 ABBOTT PARK ROAD
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact JOY C SONSALLA
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Codes
JIS   JJX  
Date Received05/31/1994
Decision Date 08/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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