Prochem Ext Chemical Integrator
FDA 510(k) K062651 · Raven Biological Laboratories, Inc.
510(k) numberK062651
Submission
- Device name
- Prochem Ext Chemical Integrator
- Applicant
- Raven Biological Laboratories, Inc.
Omaha, NE, US - Received
- September 7, 2006
- Decision date
- March 15, 2007
- 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 |
| 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 |
|---|---|---|
| K082756 | Raven Protest - Steam Biological IndicatorFRC · Traditional | 10/21/2009SE |
| K053212 | Raven PropactMRB · Special | 02/15/2006SE |
| K050591 | Modification to Raven Bacterial Spore StripsFRC · Special | 03/23/2005SE |
| K041784 | Raven Protest - EoFRC · Traditional | 09/13/2004SE |
| K041386 | Raven Protest - SteamFRC · Traditional | 08/09/2004SE |
| K032914 | Modification To:Raven Bacterial Spore StripsFRC · Traditional | 05/25/2004SE |
| K031114 | Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PAMRB · Traditional | 03/03/2004SE |
| K020026 | Raven Bacterial Spore StripsFRC · Special | 01/30/2002SE |
| K994381 | PROSPORE2 Self-Contained Biological IndicatorFRC · Traditional | 03/30/2001SE |
| K971430 | Prospore IIFRC · Traditional | 05/22/1997SE |
Questions and answers
When was Prochem Ext Chemical Integrator cleared by the FDA?
Prochem Ext Chemical Integrator (K062651) received a 510(k) decision of Substantially Equivalent on March 15, 2007, 189 days after the submission was received.
What is the product code of K062651?
The FDA product code is JOJ – Indicator, Physical/Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.