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510(k) K241959

3M Attest Super Rapid Steam Clear Challenge Pack (1492PCD); 3M Attest Auto-reader (490); 3M Attest Auto-reader (490H); 3M Attest Mini Auto-reader (490M) by 3M Company — Product Code FRC

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 18, 2024
Date Received: July 3, 2024
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Indicator, Biological Sterilization Process
Device Class: Class II
Regulation Number: 880.2800
Review Panel: HO
Submission Type

Other clearances by 3M Company

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K250061 — Celerity Incubator (February 6, 2025)
K243501 — 3M Attest Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M (January 28, 2025)
K242453 — Terragene® Bionova® Photon Process Challenge Device with unique-point integrator (December 12, 2024)
K242538 — 3M Attest Super Rapid Readout Biological Indicator 1493; 3M Attest Super Rap (November 25, 2024)
K231383 — Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Biono (September 18, 2024)
K241710 — 3M Attest Super Rapid Readout Biological Indicator 1492V; 3M Attest Auto-rea (September 12, 2024)