PROSPORE2 Self-Contained Biological Indicator
FDA 510(k) K994381 · Raven Biological Laboratories, Inc.
510(k) numberK994381
Submission
- Device name
- PROSPORE2 Self-Contained Biological Indicator
- Applicant
- Raven Biological Laboratories, Inc.
Omaha, NE, US - Received
- December 28, 1999
- Decision date
- March 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Expedited review
- Yes
Device classification
- Product code
- FRC – Indicator, Biological Sterilization Process
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.2800
- Specialty
- General Hospital
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| K082756 | Raven Protest - Steam Biological IndicatorFRC · Traditional | 10/21/2009SE |
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| 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 |
| K971430 | Prospore IIFRC · Traditional | 05/22/1997SE |
Questions and answers
When was PROSPORE2 Self-Contained Biological Indicator cleared by the FDA?
PROSPORE2 Self-Contained Biological Indicator (K994381) received a 510(k) decision of Substantially Equivalent on March 30, 2001, 458 days after the submission was received.
What is the product code of K994381?
The FDA product code is FRC – Indicator, Biological Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.