MUMPS IGG ELISA TEST SYSTEM— 510(k) K991274

Name: FDA 510(k) clearance K991274
Creator: U.S. Food and Drug Administration
Published: 1999-09-03

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K991274 for MUMPS IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-09-03. Applicant: Columbia Bioscience, Inc.. Device class: 1.

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code LJY
Device class: Class 1
Regulation: 21 CFR 866.3380
Advisory panel: Microbiology
Date received: 1999-04-13
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJY

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K980059 — SERAQUEST MUMPS IGG1998-04-23
K971857 — MUMPS IGG ELISA TESTY1997-11-04
K961204 — MUMPS IGG TEST1996-07-18
K925209 — MUMPS STAT1994-10-14
K923903 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM MUMPS IGG ASSA1993-08-09

More clearances from Columbia Bioscience, Inc.

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K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM1998-12-16
K983553 — ANTI-TG IGG ELISA TEST SYSTEM1998-12-07

Recalls naming K991274

K-number listed on FDA's recall record

Z-2573-2018 — Diamedix Is-Mumps IgG Enzyme Immunoassay Test Kit for In Vitro Diagnostic Use Catalog No. 720-540Class III·Terminated·Diamedix Corporation·20180105
Z-1685-2016 — Diamedix Is-Mumps IgG Test Kit Diamedix Is-Mumps IgG Test Kit is an EIA procedure intended for the qualitative and semi-quantitative detection of Mumps IgG antibodies as an aid in the diagnosis of Mumps infection.Class II·Terminated·Diamedix Corporation·20141020

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K991274.

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