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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Station, Pipetting And Diluting, For Clinical Use
510(k) Number K823364
Device Name COUNT-10 SYSTEM FOR STAND. URINALYSIS
Applicant
V-TECH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
V-TECH, INC.
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number862.2750
Classification Product Code
JQW  
Date Received11/09/1982
Decision Date 12/15/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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