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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mixer, Blood Tube
510(k) Number K800003
Device Name CORTEX DOUBLE HELIX SAMPLER
Applicant
CORTEX RESEARCH CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
CORTEX RESEARCH CORP.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.2050
Classification Product Code
GLE  
Date Received01/02/1980
Decision Date 02/01/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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