DIAMEDIX IS-CMV IGG TEST SYSTEM— 510(k) K981163

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K981163 for DIAMEDIX IS-CMV IGG TEST SYSTEM, Substantially Equivalent on 1998-09-21. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1998-03-31
Decision date: 1998-09-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

K220949 — Architect CMV IgG2022-10-27
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K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control2018-07-30
K163569 — Elecsys CMV IgM2017-03-17
K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set2017-01-06

More clearances from Diamedix Corp.

K093101 — MAGO 4S2011-01-21
K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM2002-07-09
K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN2002-01-08
K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM2001-12-21
K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM2001-10-26

Recalls naming K981163

K-number listed on FDA's recall record

Z-1689-2016 — Diamedix Is-CMV IgG Test KitClass II·Terminated·Diamedix Corporation·20150326

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K981163.

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