Sultan Sporox Test Vial, Model 75195
FDA 510(k) K020612 · Sultan Chemists, Inc.
510(k) numberK020612
Submission
- Device name
- Sultan Sporox Test Vial, Model 75195
- Applicant
- Sultan Chemists, Inc.
Englewood, NJ, US - Received
- February 25, 2002
- Decision date
- May 7, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| 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 |
|---|---|---|
| K052699 | Versa-Link Porcelain Bonding SystemKLE · Traditional | 11/16/2005SE |
| K052409 | Silgimix Alginate Replacement Impression MaterialELW · Traditional | 10/20/2005SE |
| K043054 | Genie Magic Mix Ultra Hydrophilic Impression MaterialELW · Traditional | 02/18/2005SE |
| K030414 | Genie Ultra Hydrophilic Impression MaterialELW · Traditional | 04/09/2003SE |
| K002843 | Sultan Sensitemp Resin Temporary Cement, Model 70010EMA · Traditional | 11/15/2000SE |
| K991509 | Pro-Portion Cleaner/DisinfectantLRJ · Traditional | 07/14/1999SE |
| K971138 | Dinabase (TM)EBI · Traditional | 07/21/1997SE |
| K951590 | Assure, Self-Sealing Sterilization PouchKCT · Traditional | 05/17/1995SE |
| K933729 | Assure Self Sealing Sterilization PouchKCT · Traditional | 06/21/1994SE |
| K896826 | Sultan Perio-Select Irrigation System · Traditional | 03/02/1990SEKD |
Questions and answers
When was Sultan Sporox Test Vial, Model 75195 cleared by the FDA?
Sultan Sporox Test Vial, Model 75195 (K020612) received a 510(k) decision of Substantially Equivalent on May 7, 2002, 71 days after the submission was received.
What is the product code of K020612?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.