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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K000042
Device Name ELECSYS B-CROSSLAPS CALCHECK
Applicant
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
Applicant Contact KAY A LAPS
Correspondent
ROCHE DIAGNOSTICS CORP.
9115 HAGUE RD.
P.O. BOX 50416
INDIANAPOLIS,  IN  46250 -0457
Correspondent Contact KAY A LAPS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received01/06/2000
Decision Date 03/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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