Spin Chem Reagents & Standards
FDA 510(k) K821184 · Smithkline Diagnostics, Inc.
510(k) numberK821184
Submission
- Device name
- Spin Chem Reagents & Standards
- Applicant
- Smithkline Diagnostics, Inc.
Mchenry, IL, US - Received
- April 27, 1982
- Decision date
- May 24, 1982
- 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
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|---|---|---|
| K961062 | Flexsure ObtKHE · Traditional | 11/06/1996SE |
| K960183 | Flexsure Hp,Controls for Flexsurehp,Flexpack Hp(Abbott Diagnostics)Andcontrols for…LYR · Traditional | 06/07/1996SE |
| K934863 | Flexsure HPLYR · Traditional | 05/18/1994SE |
| K880499 | Hemoccult Sensitive TestKHE · Traditional | 05/23/1988SE |
| K875131 | (SKD) Cholesterol Test KitCHH · Traditional | 03/01/1988SE |
| K862849 | Hemoccult Wipe TestKHE · Traditional | 12/09/1986SE |
| K854723 | SKD Electrochemical System (Ecs)CEM · Traditional | 03/05/1986SE |
| K852841 | Rapid Direct Strep a Latex Agglutination TestGTZ · Traditional | 07/24/1985SE |
| K821884 | Gastroccult TMKHE · Traditional | 10/08/1982SE |
| K821674 | Spinchem Acid Phosphatase ReagentCKB · Traditional | 06/22/1982SE |
Questions and answers
When was Spin Chem Reagents & Standards cleared by the FDA?
Spin Chem Reagents & Standards (K821184) received a 510(k) decision of Substantially Equivalent on May 24, 1982, 27 days after the submission was received.
What is the product code of K821184?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.