Serum Iron
FDA 510(k) K771838 · Gamma Enterprises, Inc.
510(k) numberK771838
Submission
- Device name
- Serum Iron
- Applicant
- Gamma Enterprises, Inc.
Mchenry, IL, US - Received
- September 21, 1977
- Decision date
- November 3, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K790578 | Gamma Smac ReagentsCIG · Traditional | 05/15/1979SE |
| K780507 | Serum Glutamic-Pyruvic TransaminaseCKC · Traditional | 05/03/1978SE |
| K780506 | Carbon Dioxide ReagentsKMS · Traditional | 05/03/1978SE |
| K780505 | Serum Glutamic-Oxaloacetic-TransaminaseCIT · Traditional | 05/03/1978SE |
| K780504 | Creatine Phosphokinase (CPK)JHS · Traditional | 05/03/1978SE |
| K771843 | Wetting Agents · Traditional | 11/22/1977SE |
| K771836 | Lactate DehydrogenaseCFJ · Traditional | 11/22/1977SE |
| K771832 | ChlorideJFS · Traditional | 11/22/1977SE |
| K771834 | CreatinineCGX · Traditional | 11/03/1977SE |
| K771839 | SodiumJGS · Traditional | 11/02/1977SE |
Questions and answers
When was Serum Iron cleared by the FDA?
Serum Iron (K771838) received a 510(k) decision of Substantially Equivalent on November 3, 1977, 43 days after the submission was received.
What is the product code of K771838?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.