Behring Coagulation System (Bcs)

by Dade Behring, Inc. 510(k)

Active United States

510(k) K992959

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK992959	Date11 Jan 2000Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K992959
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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