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FDA 510(k)

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER

K-Number: K103277 · 2011-04-19

Applicant3M Company-3M Health Care
Decision Date2011-04-19
Product CodeFRC
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER is the device name listed in this FDA 510(k) record. The listed applicant is 3M Company-3M Health Care. It received FDA 510(k) clearance on 2011-04-19 under 510(k) number K103277. 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 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER?

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER is a medical device that received FDA 510(k) clearance on 2011-04-19. The listed applicant is 3M Company-3M Health Care. The 510(k) number is K103277.

When did 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER receive FDA 510(k) clearance?

3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER received FDA 510(k) clearance on 2011-04-19, under 510(k) number K103277.

Who is the listed applicant for 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER?

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

What is the FDA product code for 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER?

The FDA product code for 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER is FRC.

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Other records listing 3M Company-3M Health Care as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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