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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 K973894
Device Name IMMUSURE
Applicant
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278 -1205
Applicant Contact EVY JOHNSON
Correspondent
QUANTIMETRIX CORP.
2005 MANHATTAN BEACH BLVD.
REDONDO BEACH,  CA  90278 -1205
Correspondent Contact EVY JOHNSON
Regulation Number862.1660
Classification Product Code
JJY  
Subsequent Product Code
DIF  
Date Received10/14/1997
Decision Date 10/29/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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