Autodelfia Neonatal Irt L Kit, Model B022-112
FDA 510(k) K070889 · Wallac OY
510(k) numberK070889
Submission
- Device name
- Autodelfia Neonatal Irt L Kit, Model B022-112
- Applicant
- Wallac OY
Turku, FI - Received
- March 30, 2007
- Decision date
- April 14, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CGZ – Electrode, Ion-Specific, Chloride
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1170
- Specialty
- Clinical Chemistry
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| K013451 | Phoenoix Ise Reagents for Roche Hitachi, Models 700/900 SeriesCGZ · Traditional | Phoenix Diagnostics, Inc. | 12/18/2001SE |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | Wallac OY | 02/14/2001SE |
More from Wallac OY
| 510(k) | Device | Decision |
|---|---|---|
| K131284 | GSP Neonatal Biotinidase KitNAK · Traditional | 11/14/2013SE |
| K100682 | GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001UJLX · Traditional | 07/23/2010SE |
| K081922 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Traditional | 04/16/2009SE |
| K071649 | Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110BJIA · Traditional | 08/07/2008SE |
| K050709 | Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367GKA · Traditional | 03/08/2006SE |
| K050960 | Modification to: Autodelfia Neonatal 17A-OH-PROGESTERONE L KitJLX · Special | 07/11/2005SE |
| K042425 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | 09/30/2004SE |
| K042424 | Delfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | 09/30/2004SE |
| K003664 | Delfia Neonatal Irt Kit, Model A005-110CGZ · Traditional | 02/14/2001SE |
| K003668 | Autodelfia Neonatal Irt Kit, Model B005-112CGZ · Traditional | 02/12/2001SE |
Questions and answers
When was Autodelfia Neonatal Irt L Kit, Model B022-112 cleared by the FDA?
Autodelfia Neonatal Irt L Kit, Model B022-112 (K070889) received a 510(k) decision of Substantially Equivalent on April 14, 2008, 381 days after the submission was received.
What is the product code of K070889?
The FDA product code is CGZ – Electrode, Ion-Specific, Chloride, a Class II (moderate risk) device regulated under 21 CFR 862.1170.