Syste Mate Iron, Hem No. 67224
FDA 510(k) K845020 · Em Diagnostic Systems, Inc.
510(k) numberK845020
Submission
- Device name
- Syste Mate Iron, Hem No. 67224
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- December 27, 1984
- Decision date
- January 28, 1985
- 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
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| 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 |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Syste Mate Iron, Hem No. 67224 cleared by the FDA?
Syste Mate Iron, Hem No. 67224 (K845020) received a 510(k) decision of Substantially Equivalent on January 28, 1985, 32 days after the submission was received.
What is the product code of K845020?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.