Medical Device Manufacturer · US , Castle Rock , CO

Steritec Products, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 2000

Recent clearances: EMU-GRAPH 4 EMULATOR, MODEL CI 144, INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105, STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140, STERITEC PROCESS INDICATOR DOTS - CI 137

View 12 510(k) Devices ↓

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Steritec Products, Inc. General Hospital ✕

12 devices

1-12 of 12

Cleared Mar 05, 2009

EMU-GRAPH 4 EMULATOR, MODEL CI 144

General Hospital · 86d

Cleared Aug 15, 2008

INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK, MODEL LT- 105

General Hospital · 206d

Cleared Oct 03, 2005

STERITEC CONTAINER CORD - CI 135, STERITEC PROCESS INDICATOR LABELS - CI 140,...

General Hospital · 19d

Cleared Sep 09, 2004

STERITEC EMU-GRAPH, MODEL NO. CI 131/US

General Hospital · 155d

Cleared Aug 11, 2003

BOWIE-DICK MINI PAK, MODEL BD 115

General Hospital · 230d

Cleared Mar 04, 2002

INTEGRAPH FLASH, MODEL CI 110

General Hospital · 200d

Cleared Aug 06, 2001

CROSS-CHECKS DUAL, MODEL CI 125

General Hospital · 164d

Cleared Feb 07, 2001

CROSS-CHECKS LF, MODEL CI 119/S &CI 119/L

General Hospital · 83d

Cleared Dec 08, 2000

STERILIZATION PROCESS INDICATOR TAPES MODEL CI112 & CI123

General Hospital · 73d

Cleared Nov 29, 2000

EO GAS STERILIZATION PROCESS INDICATOR TAPES, MODEL CI 124

General Hospital · 77d

Cleared Jun 23, 2000

STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234

General Hospital · 24d

Cleared May 15, 2000

STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI...

General Hospital · 7d