AIA-PACK FOLATE ASSAY— 510(k) K964349

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K964349 for AIA-PACK FOLATE ASSAY, Substantially Equivalent on 1996-11-27. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 1996-10-31
Decision date: 1996-11-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Foster City, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K964349

K-number listed on FDA's recall record

Z-0672-2019 — AIA-PACK Folate (FOL) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of folate in human serum on Tosoh AIA System analyzers.Class II·Terminated·Tosoh Bioscience Inc·20181130

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K964349.

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