Class Class II

Atellica IM Total PSA II (tPSAII) (K251630)

K251630 2026-01-05 Traditional
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Description

Atellica IM Total PSA II (tPSAII) by Siemens Healthcare Diagnostics, Inc., an FDA 510(k) cleared immunology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251630
Clearance Date2026-01-05
Clearance TypeTraditional
Product CodeLTJ
Regulation Number866.6010

Categories

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