BECKMAN TOTAL BILIRUBIN TRIGGERED (TB-T) KIT— 510(k) K902801

Clearance details

Applicant

Beckman Instruments, Inc.

Product code

Code CIG

Device class

Class 2

Regulation

21 CFR 862.1110

Advisory panel

Clinical Chemistry

Date received

1990-06-27

Decision date

1990-07-17

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Brea, CA, US

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• Z-1426-2020 — Total Bilirubin Reagent (TBIL 2 x 300 ) and (TBIL 2 x 400), Ref:442745 (300 tests/cartridge) and 476861 (400 tests/cartridge), For In Vitro Diagnostic Use, Rx Only, UDI: 15099590233075 (300 tests/cartridge) and 15099590625597 (400 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 K902801.