Biotrol Bicarbonate Standards

by Biotrol, USA, Inc. 510(k)

Active United States

510(k) K921855

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK921855	Date3 Aug 1992Cleared	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Withdrawn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: K921855
FDA Product Code: JIS

Device Class: Class II
Regulation: 21 CFR Part 862.1150
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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