OWP · Class II · 21 CFR 880.2805

FDA Product Code OWP: Biological Sterilization Process Indicator With Recombinant-dna Plasmid

A Recombinant-dna Plasmid Biological Indicator Is Intended For Use By A Health Care Provider To Accompany Products Being Sterilized Through A Sterilization Procedure And To Monitor Adequacy Of Sterilization.

Leading manufacturers include STERIS Corporation.

5
Total
4
Cleared
229d
Avg days
2013
Since

FDA 510(k) Cleared Biological Sterilization Process Indicator With Recombinant-dna Plasmid Devices (Product Code OWP)

5 devices
1–5 of 5
Cleared Jun 13, 2018
VERIFY Assert Self-Contained Biological Indicator
K181442
STERIS Corporation
General Hospital · 12d
Cleared Apr 28, 2017
VERIFY ASSERT STEAM Process Challenge Device
K162945
STERIS Corporation
General Hospital · 189d
Cleared Mar 24, 2017
VERIFY Assert Self-Contained Biological Indicator
K162701
STERIS Corporation
General Hospital · 177d
Cleared Mar 24, 2017
VERIFY Incubator for Assert Self Contained Biological Indicators
K163587
STERIS Corporation
General Hospital · 94d
Not Cleared Jul 12, 2013
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
DEN110006
STERIS Corporation
General Hospital · 675d

About Product Code OWP - Regulatory Context