TRUE INDICATING LLC

FDA Device Registration & Listing · Toledo, OH, US · Registration 3017524825

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
3017524825
FEI Number
3017524825
Entity Name
TRUE INDICATING LLC
City/State/Country
Toledo, OH, US
Establishment Address
946 Kane St, Suite A, Toledo, OH 43612, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
True Indicating LLC (Owner Number: 10079928)
Owner / Operator Contact Address
946 Kane St, Suite A, Toledo, OH 43612, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K210481
PMA Number
N/A

All Registered Proprietary Names

Steam Indicating Autoclave Tape True Indicating Self-Contained Biological Indicator SBI-100 MSCS-05E MSCST-05L MSCST-05SF SRI-050 Type 5 Integrating Indicator for Steam (CSPN-15) Instant 20s Indicator ISCS-05E

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2024-02-12
FRC Indicator, Biological Sterilization Process General Hospital Class 2 880.2800 2021-01-04
JOJ Indicator, Physical/Chemical Sterilization Process General Hospital Class 2 880.2800 2025-02-25
MTC Indicator, Chemical, Enzymatic, Sterilization Process General Hospital Class 2 880.2800 2021-12-17

Official Correspondent

THOMAS RIHA

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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 3017524825. Last updated year: 2026. Please use registration number 3017524825 when referencing this establishment in official correspondence.
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