Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution
FDA 510(k) K984616 · Albert Browne , Ltd.
510(k) numberK984616
Submission
- Device name
- Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution
- Applicant
- Albert Browne , Ltd.
North Attleboro, MA, US - Received
- December 29, 1998
- Decision date
- February 4, 1999
- 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
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| 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 |
|---|---|---|
| K063285 | Reliance Ci Process IndicatorJOJ · Traditional | 01/12/2007SE |
| K061738 | Albert Browne Ltd. Verify Steam and Eo Load Record CardJOJ · Traditional | 08/25/2006SE |
| K053479 | Verify Dry Heat LabelJOJ · Traditional | 07/18/2006SE |
| K060066 | Verify 3-10 Min Flash IntegratorJOJ · Traditional | 03/24/2006SE |
| K060103 | Albert Browne Ltd. Verify Steam Value IndicatorsJOJ · Special | 03/07/2006SE |
| K051101 | Verify Flash IntegratorJOJ · Traditional | 12/06/2005SE |
| K051056 | Verify Self-Contained Biological IndicatorFRC · Traditional | 10/20/2005SE |
| K032801 | Modified Browne Packaging and Label Steam Process IndicatorJOJ · Special | 10/17/2003SE |
| K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackJOJ · Traditional | 07/03/2002SE |
| K002937 | TST Control Integrator for Steam SterilizersLRT · Traditional | 11/05/2001SE |
Questions and answers
When was Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution cleared by the FDA?
Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution (K984616) received a 510(k) decision of Substantially Equivalent on February 4, 1999, 37 days after the submission was received.
What is the product code of K984616?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.