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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K020945
Device Name AXSYM INTACT PTH, MODEL 2G06
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Applicant Contact CARROLL POTTS
Correspondent
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 MEDICAL CENTER BLVD.
WEBSTER,  TX  77598
Correspondent Contact CARROLL POTTS
Regulation Number862.1545
Classification Product Code
CEW  
Subsequent Product Codes
JIT   JIX  
Date Received03/25/2002
Decision Date 05/31/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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