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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 K952148
Device Name AXSYM ULTRASENSITIVE HTSH II
Applicant
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3537
Applicant Contact LAURA L GRANITZ
Correspondent
ABBOTT LABORATORIES
DEPT. 389, AP30
200 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3537
Correspondent Contact LAURA L GRANITZ
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Codes
JIS   JJX  
Date Received05/08/1995
Decision Date 06/29/1995
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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