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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 K150955
Device Name Elecsys Progesterone III Cal Check 5
Applicant
Roche Diagnostics
Roche Professional Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Applicant Contact ADAM CLARK
Correspondent
Roche Diagnostics
Roche Professional Diagnostics
9115 Hague Rd.
Indianapolis,  IN  46250
Correspondent Contact ADAM CLARK
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/09/2015
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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