CS-400 Coagulation Analyzer System (A1208)

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K972260 ↗

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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See all devices from Sigma Diagnostics, Inc. →

• What is the CS-400 Coagulation Analyzer System used for?

  The CS-400 Coagulation Analyzer System is used to perform a series of coagulation studies and coagulation factor assays in hematology.

• Is the CS-400 Coagulation Analyzer System supplied with reagents and controls?

  Yes, the CS-400 Coagulation Analyzer System is supplied with associated reagents and controls.

• What regulatory classification does the CS-400 Coagulation Analyzer System have?

  The system is classified as a System, Multipurpose For In Vitro Coagulation Studies, and is regulated under 21 CFR 864.5425.