Steritec Disposable Biological Test Pack
FDA 510(k) K961721 · Steritec Products Mfg Co, Inc.
510(k) numberK961721
Submission
- Device name
- Steritec Disposable Biological Test Pack
- Applicant
- Steritec Products Mfg Co, Inc.
Castle Rock, CO, US - Received
- May 3, 1996
- Decision date
- August 23, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code FRC
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|---|---|---|---|
| K260766 | Celerity 5 HP Biological Indicator (LCB052)FRC · Special | STERIS Corporation | 04/08/2026SE |
| K252680 | Celerity 20 HP Biological IndicatorFRC · Special | STERIS Corporation | 09/24/2025SE |
| K251122 | Terragene® Bionova® BT20 Biological IndicatorFRC · Traditional | Terragene | 08/04/2025SE |
| K251452 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | Steris | 06/06/2025SE |
| K250061 | Celerity IncubatorFRC · Special | STERIS Corporation | 02/06/2025SE |
| K250044 | Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special | STERIS Corporation | 02/06/2025SE |
| K243501 | 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional | 3M Company | 01/28/2025SE |
| K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional | Terragene S.A. | 12/12/2024SE |
| K242538 | 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional | 3M Company | 11/25/2024SE |
| K241959 | 3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional | 3M Company | 10/18/2024SE |
More from 3M Company
| 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 Steritec Disposable Biological Test Pack cleared by the FDA?
Steritec Disposable Biological Test Pack (K961721) received a 510(k) decision of Substantially Equivalent on August 23, 1996, 112 days after the submission was received.
What is the product code of K961721?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.