Iron/Tibc Reagent
FDA 510(k) K935712 · Horizon Diagnostics, Inc.
510(k) numberK935712
Submission
- Device name
- Iron/Tibc Reagent
- Applicant
- Horizon Diagnostics, Inc.
Ann Arbor, MI, US - Received
- November 30, 1993
- Decision date
- September 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K030528 | Atac Iron Reagent, Atac Tibc Column Kit and Iron Calibrator (500 Ug/Dl)JIY · Traditional | Clinical Data | 06/17/2003SE |
| 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 |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K971566 | Creatine Kinase-Mb Reagent SetCGS · Traditional | 07/14/1997SE |
| K933722 | Horizon Diagnostics Triglycerides-Gpo ReagentCDT · Traditional | 06/13/1996SE |
| K930678 | AmylaseJFJ · Traditional | 04/06/1994SE |
| K934533 | BUN-300/BUN-500 Urea Nitrogen ReagentCDQ · Traditional | 11/26/1993SE |
| K930679 | Direct BilirubinCIG · Traditional | 06/29/1993SE |
| K930074 | In-Vitro Diagnostic Reagent SetJGJ · Traditional | 05/11/1993SE |
Questions and answers
When was Iron/Tibc Reagent cleared by the FDA?
Iron/Tibc Reagent (K935712) received a 510(k) decision of Substantially Equivalent on September 20, 1995, 659 days after the submission was received.
What is the product code of K935712?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.