Cross-Checks
FDA 510(k) K951113 · Steritec Products Mfg Co, Inc.
510(k) numberK951113
Submission
- Device name
- Cross-Checks
- Applicant
- Steritec Products Mfg Co, Inc.
Castle Rock, CO, US - Received
- March 10, 1995
- Decision date
- August 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LRT – Indicator, Sterilization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code LRT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K002937 | TST Control Integrator for Steam SterilizersLRT · Traditional | Albert Browne , Ltd. | 11/05/2001SE |
| K965154 | TST Control Integrator for Steam AutoclaveLRT · Traditional | Albert Browne , Ltd. | 09/19/1997SE |
| K951703 | Tamper Evident Arrows with and Without Sterilization IndicatorsLRT · Traditional | Products For Medicine | 06/28/1995SE |
| K871672 | Sterilization Indicator for Flash SterilizationLRT · Traditional | Propper Mfg. Co., Inc. | 06/01/1987SE |
More from Propper Mfg. Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K200252 | Getinge Assured MI Steam Migrating IntegratorJOJ · Traditional | 05/21/2020SE |
| K133549 | Steritec Biological Test Pack with Instant Readout IntegratorFRC · Traditional | 08/27/2014SE |
| K133322 | Steritec Smart-Read Biological Test Pack with Instant Readout IntegratorFRC · Traditional | 08/25/2014SE |
| K132372 | Steritec Green Card Pack Bowie-Dick TestJOJ · Traditional | 11/26/2013SE |
| K122945 | Steritec Green Card Pack Bowie-Dick Test Model BD 126JOJ · Abbreviated | 04/30/2013SE |
| K122555 | Steritec Lead Free Sterilization Process Indicator TapeJOJ · Abbreviated | 12/12/2012SE |
| K111150 | Steritec Smart-Read Biological Test Pack with Instant Readout IntegratorFRC · Traditional | 07/08/2011SE |
| K103000 | Smart Read Biological Test PackJOJ · Special | 02/11/2011SE |
| K072408 | Emu-Graph Emulator, Model Ci 131JOJ · Traditional | 04/30/2008SE |
| K000502 | Steam/Eo Record Card, Model Ci 121JOJ · Special | 03/14/2000SE |
Questions and answers
When was Cross-Checks cleared by the FDA?
Cross-Checks (K951113) received a 510(k) decision of Substantially Equivalent on August 19, 1996, 528 days after the submission was received.
What is the product code of K951113?
The FDA product code is LRT – Indicator, Sterilization, a Class II (moderate risk) device regulated under 21 CFR 880.2800.