BECKMAN DIRECT BILIRUBIN REAGENT— 510(k) K934068

Clearance details

Applicant

Beckman-Diagnostic Systems Group

Product code

Code CIG

Device class

Class 2

Regulation

21 CFR 862.1110

Advisory panel

Clinical Chemistry

Date received

1993-08-20

Decision date

1994-04-26

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brea, CA, US

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• K945522 — I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS1994-12-12
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• K942676 — SYNCHRON CX3 DELTA1994-11-02

• Z-1425-2020 — Direct Bilirubin Reagents (DBIL 2 x 200 ) and (DBIL 2 x 300), Ref:439715 (200 tests/cartridge) and 476856 (300 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590575120(200 tests/cartridge) and 15099590625603(300 tests/cartridge)Class II·Terminated·Beckman Coulter Inc·20190815

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934068.