GSP NEONATALGALT KIT, MODEL 3303-001U— 510(k) K100101

Name: FDA 510(k) clearance K100101
Creator: U.S. Food and Drug Administration
Published: 2010-06-11

Substantially Equivalent

Perkinelmer, Inc.

FDA 510(k) clearance K100101 for GSP NEONATALGALT KIT, MODEL 3303-001U, Substantially Equivalent on 2010-06-11. Applicant: Perkinelmer, Inc.. Device class: 2.

Clearance details

Applicant: Perkinelmer, Inc.
Product code: Code KQP
Device class: Class 2
Regulation: 21 CFR 862.1315
Advisory panel: Clinical Chemistry
Date received: 2010-01-13
Decision date: 2010-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K100101

K-number listed on FDA's recall record

Z-2713-2026 — GSP Neonatal GALT Kit. Product Codes: 3303-001U, 3303-0010. in vitro diagnostic. Used in FLUORESCENT PROC. (QUAL), GALACTOSE-1-PHOSPHATE URIDYL TRANSFERASE.Class II·Ongoing·WALLAC OY·20260518

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100101.

Data sourced from openFDA. This site is unofficial and independent of the FDA.