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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K802251
Device Name SP 120 SOPHISTICATE
Applicant
Vickers America Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Vickers America Medical Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.2100
Classification Product Code
JQP  
Date Received09/16/1980
Decision Date 10/23/1980
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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