HEMAGEN CMV IGG KIT— 510(k) K944438

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K944438 for HEMAGEN CMV IGG KIT, Substantially Equivalent on 1997-02-20. Applicant: Hemagen Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1994-09-12
Decision date: 1997-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

K220949 — Architect CMV IgG2022-10-27
K220911 — Elecsys CMV IgG2022-10-12
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 Hemagen Diagnostics, Inc.

K041051 — RAICHEM BUN RATE REAGENT (LIQUID)2004-06-30
K041052 — RAICHEM GLUCOSE UV (LIQUID)2004-06-30
K041009 — RAICHEM CALCIUM (OCPC) LIQUID REAGENT2004-06-25
K031101 — RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 22003-06-16
K023784 — RAICHEM HDL CHOLESTEROL USING CANTROL HDL PRECIPITATING TUBES ON THE COBAS MIRA ANAYLZER2002-12-24

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