Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

3M Attest Super Rapid 5 Steam-Plus Challenge Pack

K-Number: K193154 · 2020-02-07

Applicant3M Company
Decision Date2020-02-07
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M Attest Super Rapid 5 Steam-Plus Challenge Pack is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2020-02-07 under approval number K193154. The device is classified under product code FRC. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3M Attest Super Rapid 5 Steam-Plus Challenge Pack?

3M Attest Super Rapid 5 Steam-Plus Challenge Pack is a medical device that received FDA 510(k) clearance on 2020-02-07. It is manufactured by 3M Company. The 510(k) number is K193154.

When was 3M Attest Super Rapid 5 Steam-Plus Challenge Pack approved by the FDA?

3M Attest Super Rapid 5 Steam-Plus Challenge Pack received FDA 510(k) clearance on 2020-02-07, under approval number K193154.

What company makes 3M Attest Super Rapid 5 Steam-Plus Challenge Pack?

3M Attest Super Rapid 5 Steam-Plus Challenge Pack is manufactured by 3M Company.

What is the FDA product code for 3M Attest Super Rapid 5 Steam-Plus Challenge Pack?

The FDA product code for 3M Attest Super Rapid 5 Steam-Plus Challenge Pack is FRC.

Related Clinical Trials

NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT05183152 Non-invasive BCI-controlled Assistive Devices RECRUITING

Related PubMed Literature

PMID: 40574446 [Research on Classification of Medical Devices with Nanomaterials]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

Other Devices by 3M Company

K163207Filtek One Bulk Fill Restorative K1605463M Attest Rapid Readout Biological Indicator K1713733M Bair Hugger Model 675 Total Temperature Management System K1703213M Comply Hydrogen Peroxide Chemical Indicator 1248 K1705633M Comply Hydrogen Peroxide Indicator Tape K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader

View all 51 devices →

Related Devices (Code: FRC)

K1605463M Attest Rapid Readout Biological Indicator3M Company K151482BCR-30-min BI™ and RBIP-ST30™ Readout AccessoryBcr Diagnostics, Inc. K172474Celerity 20 HP Biological IndicatorSTERIS Corporation K172432SporView Rapid Read Biological IndicatorCrosstex/Spsmedical, A Division of Cantel Medical K163646Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader IncubatorTerragene S.A. K170427Anprolene SteriTestAndersen Sterilizers, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑