3M Comply 1248 Gas Plasma Chemical Indicator

• • Terminated Z-0027-2007 FDA Unclassified (pre-2012) ·initiated 9 Aug 2006

  3M Comply 1248 Gas Plasma Chemical Indicator Strips were manufactured with a material that may cause some of the indicators to show an inaccurate result if not read immediately after processing.

510(k) Number

K013228 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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