STERITEC PRODUCTS MFG. CO., INC.

FDA Device Registration & Listing · Englewood, CO, US · Registration 2028456

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2028456
FEI Number
1000125215
Entity Name
STERITEC PRODUCTS MFG. CO., INC.
City/State/Country
Englewood, CO, US
Establishment Address
74 INVERNESS DR E, Englewood, CO 80112, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
Getinge (Owner Number: 9057664)
Owner / Operator Contact Address
Ljungadalsgatan 11, VAXJO, SE-G 352 46, SE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K965212
PMA Number
N/A

All Registered Proprietary Names

Getinge Assured EO Biological Test Pack with 5 Controls STERITEC DISPOSABLE BIOLOGICAL TEST PACK-EO GAS Getinge Assured EO Biological Test Pack with 30 Controls Getinge Assured Steam Sterilization Indicator 4" Strip CROSS-CHECKS Getinge Assured Steam Sterilization Indicator 8" Strip STERI-PAK LF BOWIE-DICK TEST PACK Getinge Assured Bowie-Dick Test Card Green Card Bowie-Dick Test Card Getinge Assured Bowie-Dick Test Card SteriTec Green Card Bowie-Dick Test Card INSTANT READOUT CHEMICAL INTEGRATOR CHALLENGE PACK GETINGE ASSURE CHEMISIX PACK EXTENDED GETINGE ASSURE CHEMISIX PACK EMULATOR TEST PACK Getinge Assured Control Card STEAM/EO RECORD CARD Steam Biological Test Pack w/ Integ STERITEC SMART-READ BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR SteriTec Biological Test Pack with Instant Readout Integrator STERITEC CROSS-CHECKS D SteriTec Smart Read Biological Test Pack with Instant Readout Integrator Getinge Assured AccuFast Biological Test Pack w/ 5 Controls Getinge Assured AccuFast BiologicalTest Pack w/25 Controls Getinge Assured AccuView Biological Test Pack w/25 Controls Getinge Assured AccuView Biological Test Pack w/ 5 Controls SteriTec Emu-Graph 4 Emulator STERITEC INTEGRAPH SteriTec Steam Integrator X2 STERITEC CONTAINER CARD SteriTec Smart Read Biological Test Pack w/ 5 Controls SteriTec Instant Readout Chemical Integrator Challenge Pack STERITEC DISPOSABLE INTEGRATOR LOAD CHALLENGE-STEAM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2015-12-02
LRT Indicator, Sterilization General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-12-09
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2015-12-02
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2015-12-02

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Getinge
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3012092534 Getinge Group Logistics America, LLC E Windsor, NJ, US
3012068831 Getinge IC Production Poland sp. z o.o. Plewiska Wielkopolskie, PL
9616031 GETINGE DISINFECTION AB VAXJO Kronoberg, SE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K151482 Bcr Diagnostics, Inc. BCR-30-min BI™ and RBIP-ST30™ Readout Accessory 2016-02-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2007 N/A 2
3M Comply 1248 Gas Plasma Chemical Indicator Strips for use in STERRAD 100, STERRAD 100S and STERRAD 50 Sterilization Systems. Indicator for hydrogen peroxide sterilant.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2028456. Last updated year: 2026. Please use registration number 2028456 when referencing this establishment in official correspondence.
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