GSP Neonatal Biotinidase Kit
FDA 510(k) K131284 · Wallac OY
510(k) numberK131284
Submission
- Device name
- GSP Neonatal Biotinidase Kit
- Applicant
- Wallac OY
Waltham, MA, US - Received
- May 6, 2013
- Decision date
- November 14, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NAK – System, Test, Biotinidase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1118
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NAK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090123 | Neonatal Biotinidase Kit, Model 3018NAK · Traditional | Perkinelmer, Inc. | 03/05/2010SE |
| K080294 | Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitNAK · Traditional | Astoria-Pacific, Inc. | 11/04/2008SE |
| K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part No. 80-8000-13KNAK · Traditional | Astoria-Pacific, Inc. | 09/21/2001SE |
More from Astoria-Pacific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K070889 | Autodelfia Neonatal Irt L Kit, Model B022-112CGZ · Traditional | 04/14/2008SE |
| 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 GSP Neonatal Biotinidase Kit cleared by the FDA?
GSP Neonatal Biotinidase Kit (K131284) received a 510(k) decision of Substantially Equivalent on November 14, 2013, 192 days after the submission was received.
What is the product code of K131284?
The FDA product code is NAK – System, Test, Biotinidase, a Class II (moderate risk) device regulated under 21 CFR 862.1118.