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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 K904781
Device Name CHOLESTRECH L.D.X (TM) LEVEL 2 CONTROL
Applicant
Cholestrech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Applicant Contact SUSAN WILSON
Correspondent
Cholestrech Corp.
3347 Investment Blvd.
Hayward,  CA  94545
Correspondent Contact SUSAN WILSON
Regulation Number862.1660
Classification Product Code
JJY  
Date Received10/22/1990
Decision Date 12/18/1990
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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