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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K031299
Device Name ELECSYS LH CALSET II
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
indianapolis,  IN  46250 -0457
Original Contact theresa m ambrose
Regulation Number862.1150
Classification Product Code
JIT  
Date Received04/24/2003
Decision Date 05/12/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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