Biotrol Alkaline Phosphatase

by Biotrol, USA, Inc. 510(k)

Active United States

510(k) K881742

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK881742	Date8 Jul 1988Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
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: K881742
FDA Product Code: CJE

Device Class: Class II
Regulation: 21 CFR Part 862.1050
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from Biotrol, USA, Inc.

Biotrol Bicarbonate (CO2) UV Hp)

Class II
Biotrol Amylase CNPG3

Class II
Biotrol Magnesium (Magon)

Class I
Biotrol Alt/Tgp Monoreactif

Class I
Biotrol Toxo Elisa Test M

Class II
Biotrol Rub-E.I.a. Test G

Class II

See all devices from Biotrol, USA, Inc. →