Iron Qvet

FDA 510(k) K943029 · Prisma Systems

Substantially Equivalent

510(k) numberK943029

Submission

Device name
Iron Qvet
Applicant
Prisma Systems
Rome, NY, US
Received
June 27, 1994
Decision date
December 2, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JIY – Photometric Method, Iron (Non-Heme)
Device class
Class I (low risk)
Regulation
21 CFR 862.1410
Specialty
Clinical Chemistry

Other 510(k)s with product code JIY

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K061793Dimension Vista Iron Flex Reagent Cartridge and CalibratorJIY · Special Dade Behring, Inc.08/07/2006SE
K060264Dimension Iron Flex Reagent Cartridge (IRON-DF85)JIY · Traditional Dade Behring, Inc.03/08/2006SE
K051115Sentinel Iron LiquidJIY · Traditional Sentinel Ch. Srl08/25/2005SE
K033983Vitalab Iron ReagentJIY · Traditional Clinical Data, Inc.05/21/2004SE
K030528Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl)JIY · Traditional Clinical Data06/17/2003SE
K020816Iron-Pc-Sl Assay Model # 151-10, 151-26JIY · Traditional Diagnostic Chemicals , Ltd.05/14/2002SE
K013097Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003JIY · Traditional Wiener Laboratories Saic11/13/2001SE
K981241IronJIY · Traditional Abbott Laboratories05/01/1998SE
K973933Serum Iron-Sl Assay, Catalogue Numbers 157-10, 157-30JIY · Traditional Diagnostic Chemicals , Ltd.11/04/1997SE
K972363Il Test IronJIY · Traditional Instrumentation Laboratory CO08/15/1997SE

More from Instrumentation Laboratory CO

510(k)DeviceDecision
K950177CK QvetCGS · Traditional 03/03/1995SE
K943027Cholesterol QvetCHH · Traditional 01/27/1995SE
K943042Bun QvetCDN · Traditional 12/29/1994SE
K943001Magnesium QvetJGJ · Traditional 12/29/1994SE
K942997Alkaline Phosphatase (Alkp) QvetCJE · Traditional 12/29/1994SE
K942964Lactate Dehydrogenase QvetCFJ · Traditional 12/29/1994SE
K942963Glucose QvetCFR · Traditional 12/29/1994SE
K944102Ast QvetCIT · Traditional 12/13/1994SE
K943000Albumin QvetCIX · Traditional 12/13/1994SE
K943026Potassium QvetCEJ · Traditional 12/09/1994SE

Questions and answers

When was Iron Qvet cleared by the FDA?

Iron Qvet (K943029) received a 510(k) decision of Substantially Equivalent on December 2, 1994, 158 days after the submission was received.

What is the product code of K943029?

The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.