Class Class II

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306)

K231306 2023-06-01 Special
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Description

cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems by Roche Molecular Systems, Inc. — FDA 510(k) cleared microbiology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK231306
Clearance Date2023-06-01
Clearance TypeSpecial
Product CodeQQX
Regulation Number866.3981

Categories

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