Iron Reagent
FDA 510(k) K891155 · Medical Analysis Systems, Inc.
510(k) numberK891155
Submission
- Device name
- Iron Reagent
- Applicant
- Medical Analysis Systems, Inc.
Camarillo, CA, US - Received
- March 6, 1989
- Decision date
- April 18, 1989
- 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
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|---|---|---|---|
| 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 |
| 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 |
| K854305 | Dart Iron & Iron Binding Capacity ReagentCFM · Traditional | Coulter Electronics, Inc. | 11/12/1985SE |
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Questions and answers
When was Iron Reagent cleared by the FDA?
Iron Reagent (K891155) received a 510(k) decision of Substantially Equivalent on April 18, 1989, 43 days after the submission was received.
What is the product code of K891155?
The FDA product code is CFM – Bathophenanthroline, Colorimetry, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.