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U.S. Department of Health and Human Services

510(k) Premarket Notification
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1 to 10 of 21 Results
ProductCode: FRC Applicant: ADVANCED STERILIZATION PRODUCTS Decision Date To: 09/25/2024
 
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sterrad™ chemical indicator (ci) strip (14100); sterrad® sealsure® chemical indicator (ci) tape (14202nl); sterrad velocity™ biological indicator (bi) (43210) (60 count); sterrad velocity™ biological indicator (bi) (43210-30)(30 count); sterrad velocity™ reader (43220); ultra gi™ process challenge device (pcd) (43400)(30 count) Advanced Sterilization Products, Inc. K234084 07/05/2024
sterrad velocity biological indicator/process challenge device and reader Advanced Sterilization Products (ASP) K192025 01/23/2020
sterrad velocity biological indicator Advanced Sterilization Products (ASP) K182404 12/27/2018
sterrad velocity biological indictator and reader Advanced Sterilization Products (ASP) K170039 06/20/2017
sterrad cyclesure 24 biological indicator ADVANCED STERILIZATION PRODUCTS K151971 10/29/2015
sterrad 50/100s/200 test pack ADVANCED STERILIZATION PRODUCTS K130263 03/28/2014
sterrad cyclesure 24 biological indicator model 14324 ADVANCED STERILIZATION PRODUCTS K123017 12/26/2012
sterrad(r) cyclesure(r) 24 biological indicator ADVANCED STERILIZATION PRODUCTS K122044 10/04/2012
sterrad (r) 100nx duo cycle test pack ADVANCED STERILIZATION PRODUCTS K111391 09/26/2012
sterrad (r) cyclesure (r) 24 biological indicator ADVANCED STERILIZATION PRODUCTS K111375 09/14/2012
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