Spor-Test Pa Biological Indicator Kit

Q: What is the product code of K050664?

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

FDA 510(k) K050664 · Getinge USA, Inc.

Substantially Equivalent

510(k) numberK050664

Submission

Device name: Spor-Test Pa Biological Indicator Kit
Applicant: Getinge USA, Inc.
Rochester, NY, US
Received: March 15, 2005
Decision date: April 7, 2005
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FRC – Indicator, Biological Sterilization Process
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.2800
Specialty: General Hospital

Other 510(k)s with product code FRC

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K250044	Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059)…FRC · Special	STERIS Corporation	02/06/2025SE
K243501	3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M Attest…FRC · Traditional	3M Company	01/28/2025SE
K242453	Terragene® Bionova® Photon Process Challenge Device with unique-point integrator…FRC · Traditional	Terragene S.A.	12/12/2024SE
K242538	3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rapid Steam…FRC · Traditional	3M Company	11/25/2024SE
K241959	3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader…FRC · Traditional	3M Company	10/18/2024SE

More from 3M Company

510(k)	Device	Decision
K032723	Biosign STEAM-24 Biological IndicatorFRC · Special	10/01/2003SE
K031647	Biosign Ssi Biological Test Pack with Instant Readout IntegratorJOJ · Traditional	07/29/2003SE
K031259	Model 833HC Vacuum/Gravity Steam SterilizerFLE · Special	05/12/2003SE

Questions and answers

When was Spor-Test Pa Biological Indicator Kit cleared by the FDA?

Spor-Test Pa Biological Indicator Kit (K050664) received a 510(k) decision of Substantially Equivalent on April 7, 2005, 23 days after the submission was received.

What is the product code of K050664?

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