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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Biological Sterilization Process
510(k) Number K024079
Device Name ALIBI BIOLOGICAL INDICATOR, MODEL WS
Applicant
ARDEN LABORATORIES, INCORPORATED
468B STILLWATER RD.
WILLERNIE,  MN  55090 -0687
Applicant Contact ANGELEA STRANTZ
Correspondent
ARDEN LABORATORIES, INCORPORATED
468B STILLWATER RD.
WILLERNIE,  MN  55090 -0687
Correspondent Contact ANGELEA STRANTZ
Regulation Number880.2800
Classification Product Code
FRC  
Date Received12/10/2002
Decision Date 02/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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