Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl)
FDA 510(k) K030528 · Clinical Data
510(k) numberK030528
Submission
- Device name
- Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl)
- Applicant
- Clinical Data
Brea, CA, US - Received
- February 19, 2003
- Decision date
- June 17, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K061793 | Dimension Vista Iron Flex Reagent Cartridge and CalibratorJIY · Special | Dade Behring, Inc. | 08/07/2006SE |
| K060264 | Dimension Iron Flex Reagent Cartridge (IRON-DF85)JIY · Traditional | Dade Behring, Inc. | 03/08/2006SE |
| K051115 | Sentinel Iron LiquidJIY · Traditional | Sentinel Ch. Srl | 08/25/2005SE |
| K033983 | Vitalab Iron ReagentJIY · Traditional | Clinical Data, Inc. | 05/21/2004SE |
| K020816 | Iron-Pc-Sl Assay Model # 151-10, 151-26JIY · Traditional | Diagnostic Chemicals , Ltd. | 05/14/2002SE |
| K013097 | Wiener Lab.Fer-Color Aa, Model 5X 20 ML Cat.N 1492003JIY · Traditional | Wiener Laboratories Saic | 11/13/2001SE |
| K981241 | IronJIY · Traditional | Abbott Laboratories | 05/01/1998SE |
| K973933 | Serum Iron-Sl Assay, Catalogue Numbers 157-10, 157-30JIY · Traditional | Diagnostic Chemicals , Ltd. | 11/04/1997SE |
| K972363 | Il Test IronJIY · Traditional | Instrumentation Laboratory CO | 08/15/1997SE |
| K964913 | Iron ReagentJIY · Traditional | Derma Media Lab., Inc. | 02/20/1997SE |
More from Derma Media Lab., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K071706 | Envoy 500 HDL; Cholesterol Reagent Kit (Model# 55301), Calibrator Kit (Model# 55118)LBS · Traditional | 12/20/2007SE |
| K052591 | Nanopia Wide Range C-Reactive Protein (CRP) Reagent KitDCK · Traditional | 02/09/2006SE |
| K033983 | Vitalab Iron ReagentJIY · Traditional | 05/21/2004SE |
| K040631 | Vitalab Direct Bilirubin ReagentCIG · Traditional | 03/18/2004SE |
| K040534 | Vitalab Amylase ReagentJFJ · Traditional | 03/11/2004SE |
| K034000 | Vitalab Triglycerides Reagent and Vitalab CalibratorCDT · Traditional | 03/10/2004SE |
| K040508 | Vitalab Magnesium ReagentJGJ · Traditional | 03/08/2004SE |
| K040467 | Vitalab Uric Acid ReagentKNK · Traditional | 03/08/2004SE |
| K031042 | Atac Hemoglobin A1C Reagent KitLCP · Traditional | 11/03/2003SE |
| K031044 | Atac Pak Uric Acid Reagent and Atac CalibratorKNK · Traditional | 07/15/2003SE |
Questions and answers
When was Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl) cleared by the FDA?
Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl) (K030528) received a 510(k) decision of Substantially Equivalent on June 17, 2003, 118 days after the submission was received.
What is the product code of K030528?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.