DISINTEK PA Test Strips
FDA 510(k) K251035 · Serim Research
510(k) numberK251035
Submission
- Device name
- DISINTEK PA Test Strips
- Applicant
- Serim Research
Elkhart, IN, US - Received
- April 3, 2025
- Decision date
- June 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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
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|---|---|---|---|
| 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 |
| 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 |
| K241836 | Kem Medical Lead-free Chemical Indicators for Steam SterilizationJOJ · Traditional | Kem Medical Products Corporation | 09/30/2024SE |
More from Kem Medical Products Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K253863 | GUARDIAN Quick Dip Residual Chlorine (5212)FKJ · Traditional | 03/17/2026SE |
| K202565 | WAVICIDE-OPA MEC IndicatorJOJ · Traditional | 12/02/2020SE |
| K192445 | QwikCheck Chemical IndicatorsJOJ · Traditional | 04/02/2020SE |
| K120652 | Rapicide OPA-28 Test StripJOJ · Traditional | 10/12/2012SE |
| K092346 | Serim D-Cide Gta 1.5% Test Strip, Model Part Number 5171JOJ · Traditional | 01/07/2010SE |
| K083295 | Serim Disintek Gta 2.1%, Model: 5164JOJ · Traditional | 03/16/2009SE |
| K082352 | Serim Disintek Opa Test StripJOJ · Traditional | 09/25/2008SE |
| K081370 | Serim Disintek Opa Test StripJOJ · Traditional | 07/11/2008SE |
| K080712 | Serim Hisense Ultra 0.1, Part Number 5167MSY · Traditional | 05/06/2008SE |
| K052388 | Serim Peracetic Acid Chemical IndicatorJOJ · Traditional | 12/01/2005SE |
Questions and answers
When was DISINTEK PA Test Strips cleared by the FDA?
DISINTEK PA Test Strips (K251035) received a 510(k) decision of Substantially Equivalent on June 3, 2025, 61 days after the submission was received.
What is the product code of K251035?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.