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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name multi-analyte controls, all kinds (assayed)
510(k) Number K970862
Device Name SPINALSCOPICS
Original Applicant
QUANTIMETRIX CORP.
2005 manhattan beach blvd.
redondo beach,  CA  90278 1205
Original Contact evy johnson
Regulation Number862.1660
Classification Product Code
JJY  
Subsequent Product Code
JPK  
Date Received03/07/1997
Decision Date 04/08/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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