SERUM IRON/VIBC REAGENT SET— 510(k) K852161

Name: FDA 510(k) clearance K852161
Creator: U.S. Food and Drug Administration
Published: 1985-06-10

Substantially Equivalent

Livonia Diagnostics, Inc.

FDA 510(k) clearance K852161 for SERUM IRON/VIBC REAGENT SET, Substantially Equivalent on 1985-06-10. Applicant: Livonia Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Livonia Diagnostics, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1985-05-20
Decision date: 1985-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Livonia, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIY

view all

K061793 — DIMENSION VISTA IRON FLEX REAGENT CARTRIDGE AND CALIBRATOR2006-08-07
K060264 — DIMENSION IRON FLEX REAGENT CARTRIDGE (IRON-DF85)2006-03-08
K051115 — SENTINEL IRON LIQUID2005-08-25
K033983 — VITALAB IRON REAGENT2004-05-21
K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL)2003-06-17

More clearances from Livonia Diagnostics, Inc.

view all

K844283 — SGPT REAGENT SET1984-11-27
K844322 — SGOT REAGENT SET1984-11-27
K844237 — ALKALINE PHOSPHATASE REAGENT SET1984-11-20
K844156 — UREA NITROGEN REAGENT SET1984-11-13
K844182 — INORGANIC PHOSPHORUS REAGENT SET1984-11-09

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