3MTM AttestTM Mini Auto-reader 490M

Q: What is the product code of K200092?

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) K200092 · 3M

Substantially Equivalent

510(k) numberK200092

Submission

Device name: 3MTM AttestTM Mini Auto-reader 490M
Applicant: 3M
St. Paul, MN, US
Received: January 16, 2020
Decision date: April 15, 2020
Decision: Substantially Equivalent (SESE)
Type: Traditional 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

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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

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Questions and answers

When was 3MTM AttestTM Mini Auto-reader 490M cleared by the FDA?

3MTM AttestTM Mini Auto-reader 490M (K200092) received a 510(k) decision of Substantially Equivalent on April 15, 2020, 90 days after the submission was received.

What is the product code of K200092?

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