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 Rapid Readout Biological Indicator, 3M Attest Auto-reader

K-Number: K171003 · 2017-07-21

Applicant3M Company
Decision Date2017-07-21
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader is a medical device manufactured by 3M Company. It received FDA 510(k) clearance on 2017-07-21 under approval number K171003. 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, 3M Attest Auto-reader?

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader is a medical device that received FDA 510(k) clearance on 2017-07-21. It is manufactured by 3M Company. The 510(k) number is K171003.

When was 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader approved by the FDA?

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader received FDA 510(k) clearance on 2017-07-21, under approval number K171003.

What company makes 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader?

3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader is manufactured by 3M Company.

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

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

Related Clinical Trials

NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

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 K1719083M Tegaderm CHG Chlorhexidine Gluconate I.V. Securement Dressing

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.

↑