Ace Iron Reagent

FDA 510(k) K944911 · Schiapparelli Biosystems, Inc.

Substantially Equivalent

510(k) numberK944911

Submission

Device name
Ace Iron Reagent
Applicant
Schiapparelli Biosystems, Inc.
Columbia, MD, US
Received
October 5, 1994
Decision date
February 10, 1995
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

510(k)DeviceApplicantDecision
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
K991733Ace Ldl-C Reagent, Ldl-C Calibrator, Ldl-C ControlsMRR · Traditional 07/13/1999SE
K981377Ace T4 Reagent T4 CalibratorsKLI · Traditional 06/10/1998SE
K981375Ace T Uptake Reagent Tu CalibratorsKHQ · Traditional 06/10/1998SE
K973583Ace Theophylline Reagent, Theo CalibratorsKLS · Traditional 11/12/1997SE
K973582Ace Primidone Reagent, AED CalibratorsDJD · Traditional 11/12/1997SE
K973581Ace Valproic Acid Reagent, AED CalibratorsLEG · Traditional 11/12/1997SE
K973536Ace Phenobarbital Reagent/Aed CalibratorsDLJ · Traditional 11/06/1997SE
K973414Ace Phenytoin Reagent, AED CalibratorsDIP · Traditional 11/04/1997SE
K973535Ace Carbamazepine Reagent/Aed CalibratorsKLT · Traditional 10/20/1997SE
K971526Ace Hdl-C ReagentLBS · Traditional 05/21/1997SE

Questions and answers

When was Ace Iron Reagent cleared by the FDA?

Ace Iron Reagent (K944911) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 128 days after the submission was received.

What is the product code of K944911?

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