Spsmedical Sporview Pa Culture Set
FDA 510(k) K081879 · Spsmedical Supply Corp.
510(k) numberK081879
Submission
- Device name
- Spsmedical Sporview Pa Culture Set
- Applicant
- Spsmedical Supply Corp.
Rush, NY, US - Received
- July 2, 2008
- Decision date
- July 30, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRB – Indicator, Biological, Liquid Chemical Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
Other 510(k)s with product code MRB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053212 | Raven PropactMRB · Special | Raven Biological Laboratories, Inc. | 02/15/2006SE |
| K043135 | Spsmedical Sporview Pa Culture SetMRB · Traditional | Spsmedical Supply Corp. | 01/13/2005SE |
| K031114 | Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PAMRB · Traditional | Raven Biological Laboratories, Inc. | 03/03/2004SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K122024 | Spsmedical Sporview 10 Steam Self Contained Biological IndicatorFRC · Traditional | 11/26/2013SE |
| K130211 | Airview Bowie Dick; Test Pack, Indicator SheetsJOJ · Special | 07/05/2013SE |
| K111515 | Spsmedical Sporview Steam BiFRC · Traditional | 02/01/2012SE |
| K110152 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | 04/15/2011SE |
| K102363 | Spsmedical Emplus 270 F Steam Emulator Model EMP-104, EMP-1004JOJ · Traditional | 01/27/2011SE |
| K090650 | Spsmedical Vaporized Hydrogen Peroxide Chemical IndicatorsJOJ · Traditional | 10/09/2009SE |
| K070595 | Sporview Steam Self-Contained Biological IndicatorFRC · Traditional | 05/24/2007SE |
| K063799 | Steamplus Steam IntegratorJOJ · Traditional | 01/05/2007SE |
| K051173 | Spsmedical Sporview Plus Steam Bi Test PackFRC · Special | 05/27/2005SE |
| K043135 | Spsmedical Sporview Pa Culture SetMRB · Traditional | 01/13/2005SE |
Questions and answers
When was Spsmedical Sporview Pa Culture Set cleared by the FDA?
Spsmedical Sporview Pa Culture Set (K081879) received a 510(k) decision of Substantially Equivalent on July 30, 2008, 28 days after the submission was received.
What is the product code of K081879?
The FDA product code is MRB – Indicator, Biological, Liquid Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.