Biotrol Total Protein H.P.

by Biotrol, USA, Inc. 510(k)

Active United States

510(k) K882189

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK882189	Date1 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Withdrawn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: K882189
FDA Product Code: CEK

Device Class: Class II
Regulation: 21 CFR Part 862.1635
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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