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FDA 510(k)

3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H

K-Number: K192550 · 2020-06-05

Applicant3M Company
Decision Date2020-06-05
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2020-06-05 under approval number K192550. 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 Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H?

3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H is a medical device that received FDA 510(k) clearance on 2020-06-05. It is manufactured by 3M Company. The 510(k) number is K192550.

When was 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H approved by the FDA?

3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H received FDA 510(k) clearance on 2020-06-05, under approval number K192550.

What company makes 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H?

3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H is manufactured by 3M Company.

What is the FDA product code for 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H?

The FDA product code for 3MTM AttestTM Super Rapid Steam Biological Indicator 1592, 3MTM AttestTM Super Rapid Steam Challenge Pack, 3MTM AttestTM Auto- Readers 490 and 490H is FRC.

Related Clinical Trials

NCT07232667 Digital Technology for Active and Healthy Ageing in Taiwan RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED 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)

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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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