← Product Code [JOJ](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ) · K001649

# STERITEC AUTOCLAVE TAPES, MODEL CI122 & CI1234 (K001649)

_Steritec Products, Inc. · JOJ · Jun 23, 2000 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K001649

## Device Facts

- **Applicant:** Steritec Products, Inc.
- **Product Code:** [JOJ](/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ.md)
- **Decision Date:** Jun 23, 2000
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 880.2800
- **Device Class:** Class 2
- **Review Panel:** General Hospital

## Regulatory Identification

Biological sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization. Physical/chemical sterilization process indicator: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.

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**Source:** [https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K001649](https://fda.innolitics.com/submissions/HO/subpart-c%E2%80%94general-hospital-and-personal-use-monitoring-devices/JOJ/K001649)

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