Class Class II

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455)

K243455 2025-07-31 Traditional
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Description

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems by Roche Molecular Systems, Inc., an FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243455
Clearance Date2025-07-31
Clearance TypeTraditional
Product CodeQOF
Regulation Number866.3981

Categories

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