Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PA

Q: What is the product code of K031114?

The FDA product code is MRB – Indicator, Biological, Liquid Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.

FDA 510(k) K031114 · Raven Biological Laboratories, Inc.

Substantially Equivalent

510(k) numberK031114

Submission

Device name: Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PA
Applicant: Raven Biological Laboratories, Inc.
Omaha, NE, US
Received: April 8, 2003
Decision date: March 3, 2004
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

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
K081879	Spsmedical Sporview Pa Culture SetMRB · Special	Spsmedical Supply Corp.	07/30/2008SE
K053212	Raven PropactMRB · Special	Raven Biological Laboratories, Inc.	02/15/2006SE
K043135	Spsmedical Sporview Pa Culture SetMRB · Traditional	Spsmedical Supply Corp.	01/13/2005SE

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K041784	Raven Protest - EoFRC · Traditional	09/13/2004SE
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K994381	PROSPORE2 Self-Contained Biological IndicatorFRC · Traditional	03/30/2001SE
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Questions and answers

When was Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PA cleared by the FDA?

Pro-Pact Peracetic Acid Culture Test Kit, Model C-3PA (K031114) received a 510(k) decision of Substantially Equivalent on March 3, 2004, 330 days after the submission was received.

What is the product code of K031114?

The FDA product code is MRB – Indicator, Biological, Liquid Chemical Sterilization Process, a Class II (moderate risk) device regulated under 21 CFR 880.2800.