Iq Alkaline Phosphatase

by Bd Becton Dickinson Vacutainer Systems Preanalytic 510(k)

Active United States

510(k) K880344

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK880344	Date1 Mar 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Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number: K880344
FDA Product Code: CJK

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

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