3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER— 510(k) K103277

Name: FDA 510(k) clearance K103277
Creator: U.S. Food and Drug Administration
Published: 2011-04-19

Substantially Equivalent

3M Company-3M Health Care

FDA 510(k) clearance K103277 for 3M ATTEST 1491 SUPER RAPID READOUT BIOLOGICAL INDICATOR; 3M ATTEST 490 AUTO-READER, Substantially Equivalent on 2011-04-19. Applicant: 3M Company-3M Health Care. Device class: 2.

Clearance details

Applicant: 3M Company-3M Health Care
Product code: Code FRC
Device class: Class 2
Regulation: 21 CFR 880.2800
Advisory panel: General Hospital
Date received: 2010-11-05
Decision date: 2011-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K103277

K-number listed on FDA's recall record

Z-2002-2014 — 3M Attest Auto-reader. Model numbers 390, 390G,and 490. These devices incubate the biological indicators (BIs) to determine a positive or negative result for the sterilization cycle.Class II·Terminated·3M Company - Health Care Business·20140609

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K103277.

Data sourced from openFDA. This site is unofficial and independent of the FDA.