SERUM IRON & IRON BINDING REAGENT SET— 510(k) K860478

Name: FDA 510(k) clearance K860478
Creator: U.S. Food and Drug Administration
Published: 1986-03-14

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860478 for SERUM IRON & IRON BINDING REAGENT SET, Substantially Equivalent on 1986-03-14. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code JIY
Device class: Class 1
Regulation: 21 CFR 862.1410
Advisory panel: Clinical Chemistry
Date received: 1986-02-07
Decision date: 1986-03-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, 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 Sterling Diagnostics, Inc.

view all

K921412 — MICROPROTEIN REAGENT SET1993-01-21
K914609 — TRIGLYCERIDES REAGENT SET1991-11-07
K914039 — SODIUM REAGENT SET1991-10-31
K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

Recalls naming K860478

K-number listed on FDA's recall record

Z-0933-2017 — Sterling Diagnostics, Inc. Serum Iron/IBC (Colorimetric) for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.Class III·Terminated·Sterling Diagnostics, Inc.·20160720

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K860478.

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