Sickle Hemoglobin (Hba/S) Control Set

by Creative Laboratory Products, Inc. 510(k)

Active United States

510(k) K913427

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK913427	Date19 Nov 1991Cleared	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Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number: K913427
FDA Product Code: JCM

Device Class: Class II
Regulation: 21 CFR Part 864.7415
Advisory Committee: Hematology
FDA Decision: SESE Substantially Equivalent

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