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Steritec Products, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
13
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K252306Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge DevicApril 22, 2026
K083650EMU-GRAPH 4 EMULATOR, MODEL CI 144March 5, 2009
K080136INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105August 15, 2008
K052516STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICOctober 3, 2005
K040901STERITEC EMU-GRAPH, MODEL NO. CI 131/USSeptember 9, 2004
K024293BOWIE-DICK MINI PAK, MODEL BD 115August 11, 2003
K012732INTEGRAPH FLASH, MODEL CI 110March 4, 2002
K010534CROSS-CHECKS DUAL, MODEL CI 125August 6, 2001
K003533CROSS-CHECKS LF, MODEL CI 119/S &CI 119/LFebruary 7, 2001
K003002STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123December 8, 2000
K002861EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124November 29, 2000
K001649STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234June 23, 2000
K001444STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103May 15, 2000