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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 K935219
Device Name FERTILITY PLUS 1, 2, 3
Applicant
Ciba Corning Diagnostics Corp.
490 San Antonio Rd.
Palo Alto,  CA  94306
Applicant Contact RONALD D SCHAEFER
Correspondent
Ciba Corning Diagnostics Corp.
490 San Antonio Rd.
Palo Alto,  CA  94306
Correspondent Contact RONALD D SCHAEFER
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/26/1993
Decision Date 03/22/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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