Total Bilirubin Reagent Kit for Astra Systems

by A-Kem, Inc. 510(k)

Active United States

510(k) K884224

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK884224	Date15 Dec 1988Cleared	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Withdrawn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: K884224
FDA Product Code: CIG

Device Class: Class II
Regulation: 21 CFR Part 862.1110
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from A-Kem, Inc.

Sodium/Potassium Reagent Kit

Class II
Carbon Dioxide Reagent Kit

Class II
Glucose Reagent Kit

Class II
Calibrator Standard Kit for Astra System

Class II
Bun Reagent Kit

Class II
Total Protein Reagent Kit for Astra Systems

Class II

See all devices from A-Kem, Inc. →