Direct Iron Reagent Set
FDA 510(k) K834396 · Seragen Diagnostics, Inc.
510(k) numberK834396
Submission
- Device name
- Direct Iron Reagent Set
- Applicant
- Seragen Diagnostics, Inc.
Mchenry, IL, US - Received
- December 14, 1983
- Decision date
- February 21, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1410
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CFM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K984119 | Wako L-Type Fe, Wako L-Type CalibratorCFM · Traditional | Wako Chemicals USA, Inc. | 01/15/1999SE |
| K981581 | IronCFM · Traditional | Abbott Laboratories | 06/08/1998SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | Catachem, Inc. | 09/08/1993SE |
| K913705 | Abbott Qluickstart Iron Test, Item #5A29CFM · Traditional | Em Diagnostic Systems, Inc. | 10/09/1991SE |
| K912912 | Synermed Serum IRON-600 Reagent KitCFM · Traditional | Synermed, Inc. | 07/30/1991SE |
| K902918 | Synermed Serum Iron Reagent KitCFM · Traditional | Synermed, Inc. | 07/31/1990SE |
| K895047 | Clinistat Potassium Reagent TestCFM · Traditional | Heraeus Kulzer, Inc. | 10/17/1989SE |
| K891155 | Iron ReagentCFM · Traditional | Medical Analysis Systems, Inc. | 04/18/1989SE |
| K873120 | Abbott A-Gent Iron Reagent KitCFM · Traditional | Abbott Laboratories | 08/25/1987SE |
| K861602 | Total Iron Binding Capacity ProcedureCFM · Traditional | Data Medical Associates, Inc. | 05/23/1986SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
Questions and answers
When was Direct Iron Reagent Set cleared by the FDA?
Direct Iron Reagent Set (K834396) received a 510(k) decision of Substantially Equivalent on February 21, 1984, 69 days after the submission was received.
What is the product code of K834396?
The FDA product code is CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.