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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 K992900
Device Name PRECINORM UNIVERSAL AND PRECIPATH UNIVERSAL CONTROL SERA
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact PRICILLA A HAMILL
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50457
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact PRICILLA A HAMILL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/30/1999
Decision Date 11/24/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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