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FDA 510(k)

3M ATTEST(TM) AUTO-READER

K-Number: K123546 · 2013-03-18

Applicant3M Company
Decision Date2013-03-18
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M ATTEST(TM) AUTO-READER is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company. It received FDA 510(k) clearance on 2013-03-18 under 510(k) number K123546. 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(TM) AUTO-READER?

3M ATTEST(TM) AUTO-READER is a medical device that received FDA 510(k) clearance on 2013-03-18. The listed applicant is 3M Company. The 510(k) number is K123546.

When did 3M ATTEST(TM) AUTO-READER receive FDA 510(k) clearance?

3M ATTEST(TM) AUTO-READER received FDA 510(k) clearance on 2013-03-18, under 510(k) number K123546.

Who is the listed applicant for 3M ATTEST(TM) AUTO-READER?

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

What is the FDA product code for 3M ATTEST(TM) AUTO-READER?

The FDA product code for 3M ATTEST(TM) AUTO-READER is FRC.

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Other records listing 3M Company as applicant

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.

K2435013M™ Attest™ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2425383M™ Attest™ Super Rapid Readout Biological Indicator 1493; 3M™ Attest™ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2419593M™ Attest™ Super Rapid Steam Clear Challenge Pack (1492PCD); 3M™ Attest™ Auto-reader (490); 3M™ Attest™ Auto-reader (490H); 3M™ Attest™ Mini Auto-reader (490M)K2417103M™ Attest™ Super Rapid Readout Biological Indicator 1492V; 3M™ Attest™ Auto-reader 490; 3M™ Attest™ Auto-reader 490H; 3M™ Attest™ Mini Auto-reader 490MK2415423M™ Attest™ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack 1295PCD (1295PCD)K2407173M™ Attest™ Rapid Readout Biological Indicator 1295 and 3M™ Attest™ Vaporized Hydrogen Peroxide Tri-Metric Chemical Indicator 1348/1348E

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Related Devices (Code: FRC)

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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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