Class Class II

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) (K231383)

K231383 2024-09-18 Traditional
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Description

Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40) by Terragene S.A. — FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK231383
Clearance Date2024-09-18
Clearance TypeTraditional
Product CodeFRC
Regulation Number880.2800

Categories

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