AUTODELFIA NEONATAL IRT KIT— 510(k) K110274

Name: FDA 510(k) clearance K110274
Creator: U.S. Food and Drug Administration
Published: 2011-06-10

Substantially Equivalent

Wallac Oy, A Subsidiary of Perkinelmer, Inc.

FDA 510(k) clearance K110274 for AUTODELFIA NEONATAL IRT KIT, Substantially Equivalent on 2011-06-10. Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.. Device class: 1.

Clearance details

Applicant: Wallac Oy, A Subsidiary of Perkinelmer, Inc.
Product code: Code JNO
Device class: Class 1
Regulation: 21 CFR 862.1725
Advisory panel: Clinical Chemistry
Date received: 2011-01-31
Decision date: 2011-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K110274

K-number listed on FDA's recall record

Z-1220-2018 — AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212Class III·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·20170925

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K110274.

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