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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 K853553
Device Name DIASCAN CONTROL
Applicant
Home Diagnostics, Inc.
51 James Way
Eatontown,  NJ  07724
Applicant Contact JERRY B SLAVEN
Correspondent
Home Diagnostics, Inc.
51 James Way
Eatontown,  NJ  07724
Correspondent Contact JERRY B SLAVEN
Regulation Number862.1660
Classification Product Code
JJX  
Date Received08/26/1985
Decision Date 09/16/1985
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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