Proof (Biological/Chemical Indicator)
FDA 510(k) K801109 · Amsco Co.
510(k) numberK801109
Submission
- Device name
- Proof (Biological/Chemical Indicator)
- Applicant
- Amsco Co.
Mchenry, IL, US - Received
- May 12, 1980
- Decision date
- May 30, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOJ – Indicator, Physical/Chemical Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code JOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260181 | LF Process Indicator Tape for Steam SterilizationJOJ · Special | Intertape Polymer Group | 02/20/2026SE |
| K251991 | SafeSecure Steam Sterilization Process Indicator (4012, 4013, 4014, 4016); SafeSecure…JOJ · Traditional | Shenzhen Safesecure Medical Infection Control… | 12/23/2025SE |
| K251035 | DISINTEK PA Test StripsJOJ · Traditional | Serim Research | 06/03/2025SE |
| K251048 | Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118JOJ · Special | STERIS Corporation | 05/02/2025SE |
| K243876 | VERIFY STEAM Integrating IndicatorJOJ · Special | STERIS Corporation | 04/25/2025SE |
| K250172 | Green Card Bowie-Dick Test (BD115)JOJ · Special | Steritec Products, Inc. (A Getinge Company) | 02/20/2025SE |
| K242860 | Type 5 Integrating Indicator for Steam (CSPN-15)JOJ · Traditional | True Indicating, LLC | 01/17/2025SE |
| K241036 | Autoclave Indicator Tape; EO Indicator TapeJOJ · Traditional | Jiangmen New Era External Use Drug Co., Ltd. | 12/17/2024SE |
| K243475 | Chemical Indicator for enspire CLCSPS (LCC015)JOJ · Special | STERIS Corporation | 12/04/2024SE |
| K242795 | Getinge Assured MI Steam Migrating IntegratorJOJ · Special | Steritec Products Mfg. (A Getinge Group Company) | 10/15/2024SE |
More from Steritec Products Mfg. (A Getinge Group Company)
| 510(k) | Device | Decision |
|---|---|---|
| K912471 | Eagle 3000 SDSFLE · Traditional | 06/26/1992SE |
| K854922 | Amsco Polaris SLFSY · Traditional | 01/24/1986SE |
| K833187 | Hall OsteonGET · Traditional | 10/31/1983SE |
| K832945 | Eagle 2000 Sterilizer Series Gas/AeraFLF · Traditional | 10/19/1983SE |
| K832188 | Hall ReciprocatorGET · Traditional | 08/12/1983SE |
| K832187 | Hall OscillatorGET · Traditional | 08/12/1983SE |
| K832186 | Hall Drill/ReamerGET · Traditional | 08/12/1983SE |
| K831086 | Ceiling Mounted SupportFQO · Traditional | 08/12/1983SE |
| K831309 | Delivery 4 TableKNC · Traditional | 06/15/1983SE |
| K823360 | Surgical LightFTD · Traditional | 12/03/1982SE |
Questions and answers
When was Proof (Biological/Chemical Indicator) cleared by the FDA?
Proof (Biological/Chemical Indicator) (K801109) received a 510(k) decision of Substantially Equivalent on May 30, 1980, 18 days after the submission was received.
What is the product code of K801109?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.