HEMAGEN CHAGAS' KIT (EIA METHOD)— 510(k) K930272

Name: FDA 510(k) clearance K930272
Creator: U.S. Food and Drug Administration
Published: 1995-05-19

Substantially Equivalent

Hemagen Diagnostics, Inc.

FDA 510(k) clearance K930272 for HEMAGEN CHAGAS' KIT (EIA METHOD), Substantially Equivalent on 1995-05-19. Applicant: Hemagen Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Hemagen Diagnostics, Inc.
Product code: Code MIU
Device class: Class 1
Regulation: 21 CFR 866.3870
Advisory panel: Microbiology
Date received: 1993-01-19
Decision date: 1995-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MIU

view all

K161947 — Chagas Detect Plus Rapid Test2016-12-16
K072732 — ORTHO T. CRUZI ELISA TEST SYSTEM2009-04-15
K023889 — WIENER LAB. CHAGATEST ELISA RECOMNINANTE V.3.0, MODEL 96 TESTS CAT. NR. 12032542004-02-11
K933716 — ABBOTT CHAGAS ANTIBODY EIA1994-12-19
K911233 — CHAGAS' IGG ELISA TEST1992-05-04

More clearances from Hemagen Diagnostics, Inc.

view all

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.