OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT— 510(k) K963139

Name: FDA 510(k) clearance K963139
Creator: U.S. Food and Drug Administration
Published: 1997-02-06

Substantially Equivalent

Olympus America, Inc.

FDA 510(k) clearance K963139 for OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT, Substantially Equivalent on 1997-02-06. Applicant: Olympus America, Inc.. Device class: 2.

Clearance details

Applicant: Olympus America, Inc.
Product code: Code DDD
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 1996-08-12
Decision date: 1997-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melville, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K963139

K-number listed on FDA's recall record

Z-0309-2024 — AU/DxC AU Chemistry Transferrin REF: OSR6152 Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incident light due to reflection, absorption, or scatter. In the procedure, the measurement of the decrease in light transmitted (increase in absorbance) through particles suspended in solution as a result of complexes formed during the antigen-antibody reaction, is the basis of this assay.Class II·Ongoing·Beckman Coulter Biomedical Division·20230906

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K963139.

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