Total Iron for Continuous Flow Instruments
FDA 510(k) K883792 · Catachem, Inc.
510(k) numberK883792
Submission
- Device name
- Total Iron for Continuous Flow Instruments
- Applicant
- Catachem, Inc.
Port Chester, NY, US - Received
- September 7, 1988
- Decision date
- October 12, 1988
- 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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|---|---|---|---|
| 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 |
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| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | 01/19/2007SE |
| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | 02/22/1995SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | 09/08/1993SE |
| K903341 | MagnesiumJGJ · Traditional | 08/22/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | 07/31/1990SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | 07/27/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | 12/21/1989SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | 12/05/1989SE |
| K894715 | Creatine Kinase for Manual/Automated ApplicationsCGS · Traditional | 11/08/1989SE |
| K894476 | Calcium (Arsenazo III) for Manual/Auto ApplicationCJY · Traditional | 10/12/1989SE |
Questions and answers
When was Total Iron for Continuous Flow Instruments cleared by the FDA?
Total Iron for Continuous Flow Instruments (K883792) received a 510(k) decision of Substantially Equivalent on October 12, 1988, 35 days after the submission was received.
What is the product code of K883792?
The FDA product code is JIY – Photometric Method, Iron (Non-Heme), a Class I (low risk) device regulated under 21 CFR 862.1410.