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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, chemistry (sequential multiple, continuous flow) clinical use
510(k) Number K813077
Device Name TECHNICON RA 1000 SYSTEM
Applicant
TECHNICON CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
TECHNICON CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.2150
Classification Product Code
JJC  
Date Received11/02/1981
Decision Date 11/16/1981
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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