FDA 510(k)

3MTM AttestTM Rapid 5 Steam-Plus Test Pack

K-Number: K200536 · 2020-06-01

Decision Date2020-06-01

Product CodeFRC

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is a medical device manufactured by 3M Complany. It received FDA 510(k) clearance on 2020-06-01 under approval number K200536. 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 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is a medical device that received FDA 510(k) clearance on 2020-06-01. It is manufactured by 3M Complany. The 510(k) number is K200536.

When was 3MTM AttestTM Rapid 5 Steam-Plus Test Pack approved by the FDA?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack received FDA 510(k) clearance on 2020-06-01, under approval number K200536.

What company makes 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is manufactured by 3M Complany.

What is the FDA product code for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

The FDA product code for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack is FRC.

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.