Ferrofast
FDA 510(k) K863109 · J. D. Assoc.
510(k) numberK863109
Submission
- Device name
- Ferrofast
- Applicant
- J. D. Assoc.
Montclair, NJ, US - Received
- August 13, 1986
- Decision date
- November 24, 1986
- 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 |
|---|---|---|
| K863103 | Peg 6,000CHH · Traditional | 01/13/1987SE |
| K863054 | Ast S.C.E. (Got)CIT · Traditional | 01/13/1987SE |
| K863069 | MagnesiometerJGJ · Traditional | 12/31/1986SE |
| K863079 | CreatinkineticCGX · Traditional | 12/12/1986SE |
| K863112 | ProteinmeterJGP · Traditional | 12/10/1986SE |
| K863068 | LDH S.C.E.CFJ · Traditional | 12/10/1986SE |
| K863053 | Alt S.C.E. (GPT)CKA · Traditional | 12/10/1986SE |
| K863066 | TransfermeterJQF · Traditional | 12/04/1986SE |
| K863102 | Glucometer-ECGA · Traditional | 11/24/1986SE |
| K863056 | Bilirubin TotalCIG · Traditional | 11/24/1986SE |
Questions and answers
When was Ferrofast cleared by the FDA?
Ferrofast (K863109) received a 510(k) decision of Substantially Equivalent on November 24, 1986, 103 days after the submission was received.
What is the product code of K863109?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.