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FDA 510(k)

3MTM AttestTM Rapid 5 Steam-Plus Test Pack

K-Number: K200536 · 2020-06-01

Applicant3M Complany
Decision Date2020-06-01
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3MTM AttestTM Rapid 5 Steam-Plus Test Pack is the device name listed in this FDA 510(k) record. The listed applicant is 3M Complany. It received FDA 510(k) clearance on 2020-06-01 under 510(k) 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. The listed applicant is 3M Complany. The 510(k) number is K200536.

When did 3MTM AttestTM Rapid 5 Steam-Plus Test Pack receive FDA 510(k) clearance?

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

Who is the listed applicant for 3MTM AttestTM Rapid 5 Steam-Plus Test Pack?

The FDA 510(k) record lists 3M Complany as the applicant. This does not by itself establish the device manufacturer.

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)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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