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FDA 510(k) Applications Submitted by Michelle Larsen
FDA 510(k) Number
Submission Date
Device Name
Applicant
K241710
06/14/2024
3MÖ AttestÖ Super Rapid Readout Biological Indicator 1492V; 3MÖ AttestÖ Auto-reader 490; 3MÖ AttestÖ Auto-reader 490H; 3MÖ AttestÖ Mini Auto-reader 490M
3M Company
K241959
07/03/2024
3MÖ AttestÖ Super Rapid Steam Clear Challenge Pack (1492PCD); 3MÖ AttestÖ Auto-reader (490); 3MÖ AttestÖ Auto-reader (490H); 3MÖ AttestÖ Mini Auto-reader (490M)
3M Company
K242538
08/26/2024
3MÖ AttestÖ Super Rapid Readout Biological Indicator 1493; 3MÖ AttestÖ Super Rapid Steam Gravity Clear Challenge Pack 1493PCDG; 3MÖ AttestÖ Auto-reader 490; 3MÖ AttestÖ Auto-reader 490H; 3MÖ AttestÖ Mini Auto-reader 490M
3M Company
DEN230068
09/29/2023
3MÖ AttestÖ eBowie-Dick Test Card 10135 3MÖ AttestÖ eBowie-Dick Card Holder 10135CH 3MÖ AttestÖ eBowie-Dick Auto-reader 1190
3M Company
K243501
11/12/2024
3MÖ AttestÖ Super Rapid Steam Extended Cycle Clear Challenge Pack 1492PCDE; 3MÖ AttestÖ Auto-reader 490; 3MÖ AttestÖ Auto-reader 490H; 3MÖ AttestÖ Mini Auto-reader 490M
3M Company
K233814
11/30/2023
3MÖ AttestÖ Super Rapid Vaporized Hydrogen Peroxide Clear Challenge Pack (1295PCD); 3MÖ AttestÖ Auto-reader (490); 3MÖ AttestÖ Auto-reader (490H); 3MÖ AttestÖ Mini Auto-reader (490M)
3M Company
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