GSP Neonatal Total Galactose kit

by Perkinelmer, Inc. 510(k)

Active United States

510(k) K190335

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK190335	Date6 Nov 2019Cleared	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Withdrawn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: K190335
FDA Product Code: JIA

Device Class: Class I
Regulation: 21 CFR Part 862.1310
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

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