Iron Test

by Sclavo, Inc. 510(k)

Active United States

510(k) K881202

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK881202	Date28 Apr 1988Cleared	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Withdrawn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: K881202
FDA Product Code: JIY

Device Class: Class I
Regulation: 21 CFR Part 862.1410
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from Sclavo, Inc.

C-Reactive Protein Test Kit

Class II
Isoenzyme Test Ck-Mb

Class II
New Enzymatic Single Reagent Free Chol.

Class I
Acp Kinetic Test (Acid Phosphatase Test)

Class II
Diagnostic Kit, Cpk

Class II
Total Iron Binding Capacity Test

Class I

See all devices from Sclavo, Inc. →