FDA.reportPublic FDA data

510(k) DEN110006

Device
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL INDICATOR
Applicant
STERIS Corporation
510(k) number
DEN110006
Product code
OWP
Decision
Unknown (DENG)
Decision date
2013-07-12
Date received
2011-09-06
Regulation
880.2805
Classification name
Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Post-NSE
Third party reviewed
N

Applicant Contact#

Contact
ROBERT SULLIVAN
Address
5960 Heisley Rd. Mentor OH US 44060 44060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code OWP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K181442VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation2018-06-13
K162945VERIFY ASSERT STEAM Process Challenge DeviceSTERIS Corporation2017-04-28
K162701VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation2017-03-24
K163587VERIFY Incubator for Assert Self Contained Biological IndicatorsSTERIS Corporation2017-03-24