Ati(R) Disp Biological-Plus Test Pack
FDA 510(k) K925745 · Pymah Corp.
510(k) numberK925745
Submission
- Device name
- Ati(R) Disp Biological-Plus Test Pack
- Applicant
- Pymah Corp.
Somerville, NJ, US - Received
- November 13, 1992
- Decision date
- February 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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| 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 |
|---|---|---|
| K952995 | Ati Ethylene Oxide Sterilization IndicatorJOJ · Traditional | 02/22/1996SE |
| K952408 | Ati Disposable Test Pack for Steam SterilizationJOJ · Traditional | 07/06/1995SE |
| K951063 | Ati Disposable Test Pack for Eo Gas SterilizationJOJ · Traditional | 05/10/1995SE |
| K934874 | Sterigage Eo 100%JOJ · Traditional | 04/18/1995SE |
| K943081 | Trimline 2000DXN · Traditional | 01/27/1995SE |
| K925496 | Ati Disposable Biological-Plus Test PackFRC · Traditional | 02/01/1994SE |
| K934180 | Slimline 3000DXQ · Traditional | 11/24/1993SE |
| K924681 | Glutaraldehyde MonitorsJOJ · Traditional | 11/17/1993SE |
| K925744 | Tempa-Kuff Single Pat Pre-Gaged Balanced Disp CuffDXQ · Traditional | 07/30/1993SE |
| K930604 | Balanced(Tm) Nylon BladderDXQ · Traditional | 04/30/1993SE |
Questions and answers
When was Ati(R) Disp Biological-Plus Test Pack cleared by the FDA?
Ati(R) Disp Biological-Plus Test Pack (K925745) received a 510(k) decision of Substantially Equivalent on February 1, 1994, 445 days after the submission was received.
What is the product code of K925745?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.