Phosphorus Test Kit

by Mallinckrodt Critical Care 510(k)

Active United States

510(k) K771848

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK771848	Date28 Oct 1977Cleared	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Withdrawn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: K771848
FDA Product Code: CEO

Device Class: Class I
Regulation: 21 CFR Part 862.1580
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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