IS-VZU IGG TEST SYSTEM— 510(k) K981867

Substantially Equivalent

Diamedix Corp.

FDA 510(k) clearance K981867 for IS-VZU IGG TEST SYSTEM, Substantially Equivalent on 1998-09-28. Applicant: Diamedix Corp.. Device class: 2.

Clearance details

Applicant: Diamedix Corp.
Product code: Code LFY
Device class: Class 2
Regulation: 21 CFR 866.3900
Advisory panel: Microbiology
Date received: 1998-05-28
Decision date: 1998-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFY

K231214 — LIAISON VZV IgG HT, LIAISON Control VZV IgG HT2023-10-27
K150375 — LIAISON VZV IgG, LIAISON Control VZV IgG2015-03-11
K070317 — ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM2007-07-05
K061820 — DIASORIN LIAISON VZV IGG2007-02-26
K051484 — ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.2005-12-05

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

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