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FDA 510(k)

3M Attest Rapid Readout Biological Indicator, 1295

K-Number: K211705 · 2022-06-28

Applicant3M Company
Decision Date2022-06-28
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M Attest Rapid Readout Biological Indicator, 1295 is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2022-06-28 under approval number K211705. 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 Rapid Readout Biological Indicator, 1295?

3M Attest Rapid Readout Biological Indicator, 1295 is a medical device that received FDA 510(k) clearance on 2022-06-28. It is manufactured by 3M Company. The 510(k) number is K211705.

When was 3M Attest Rapid Readout Biological Indicator, 1295 approved by the FDA?

3M Attest Rapid Readout Biological Indicator, 1295 received FDA 510(k) clearance on 2022-06-28, under approval number K211705.

What company makes 3M Attest Rapid Readout Biological Indicator, 1295?

3M Attest Rapid Readout Biological Indicator, 1295 is manufactured by 3M Company.

What is the FDA product code for 3M Attest Rapid Readout Biological Indicator, 1295?

The FDA product code for 3M Attest Rapid Readout Biological Indicator, 1295 is FRC.

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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.

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