Koagulab 16-S Semi-Automated Coagulation Sys

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853328 ↗

FDA Product Code

JPA

Device Class

Class II

Regulation

21 CFR Part 864.5425

Advisory Committee

Hematology

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K953981 Active Cleared 30 Nov 1995

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  FDA 510(k) K862537 Active Cleared 21 Jul 1986

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