OLYMPUS LIPASE REAGENT— 510(k) K963424

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K963424 for OLYMPUS LIPASE REAGENT, Substantially Equivalent on 1997-01-14. Applicant: Olympus America, Inc.. Device class: 1.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1996-08-30
Decision date: 1997-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K963424

K-number listed on FDA's recall record

Z-1023-2015 — Beckman Coulter, Lipase Assay, Catalog No. OSR6X30Class II·Terminated·Beckman Coulter Inc.·20141215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963424.

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