Ati Disposable Biological Test Pack
FDA 510(k) K855120 · Parke-Davis Co.
510(k) numberK855120
Submission
- Device name
- Ati Disposable Biological Test Pack
- Applicant
- Parke-Davis Co.
Rochester, MI, US - Received
- December 23, 1985
- Decision date
- June 18, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K861725 | Intracath Intravenous Catheter Placement UnitFOZ · Traditional | 12/04/1986SE |
| K862119 | Deseret Flo-Thru Injectate Temperature SensorDYG · Traditional | 08/29/1986SE |
| K860570 | Angio-Flo Continuous Arterial Cath Flush DeviceKRA · Traditional | 03/31/1986SE |
| K860290 | Viapic Central Line CatheterFOZ · Traditional | 03/18/1986SE |
| K852192 | Disposable Steam Biological Test PackFRC · Traditional | 11/01/1985SE |
| K841967 | Deseret Thermodilution Cardiac OutputDXG · Traditional | 08/19/1985SE |
| K851327 | Deseret Arterial CatheterFOZ · Traditional | 06/14/1985SE |
| K852078 | Spectrum(Tentative)FOZ · Traditional | 06/07/1985SE |
| K844840 | Deseret Introducer SetDYB · Traditional | 05/16/1985SE |
| K850505 | Deseret Epidural Catheter W/Toughy-Borst AdapterBSO · Traditional | 03/11/1985SE |
Questions and answers
When was Ati Disposable Biological Test Pack cleared by the FDA?
Ati Disposable Biological Test Pack (K855120) received a 510(k) decision of Substantially Equivalent on June 18, 1986, 177 days after the submission was received.
What is the product code of K855120?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.