Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B
FDA 510(k) K071649 · Wallac OY
510(k) numberK071649
Submission
- Device name
- Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B
- Applicant
- Wallac OY
Waltham, MA, US - Received
- June 18, 2007
- Decision date
- August 7, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIA – Enzymatic Methods, Galactose
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1310
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JIA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K190335 | GSP Neonatal Total Galactose kitJIA · Traditional | Perkinelmer, Inc. | 11/06/2019SE |
| K133652 | GSP Neonatal Total Galactose KitJIA · Traditional | Wallac Oy, A Subsidiary of Perkinelmer, Inc. | 04/28/2014SE |
| K121101 | Spotcheck Neonatal Total Galactose Microplate Reagent KitJIA · Traditional | Astoria-Pacific, Inc. | 06/20/2013SE |
| K990654 | Quantase Total Galactose Screening Assay 500 Test KitJIA · Traditional | Quantase , Ltd. | 06/21/1999SE |
| K990644 | Quantase Total Galactose Screening AssayJIA · Traditional | Quantase , Ltd. | 06/21/1999SE |
| K991498 | Accuwell Total Galactose, Model 6010-EGALJIA · Traditional | Neometrics, Inc. | 06/16/1999SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | Isolab, Inc. | 02/01/1996SE |
| K951329 | Immuchem Gal-Mw EaJIA · Traditional | Icn Pharmaceuticals, Inc. | 11/09/1995SE |
More from Icn Pharmaceuticals, Inc.
| 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 |
| 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 Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B cleared by the FDA?
Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B (K071649) received a 510(k) decision of Substantially Equivalent on August 7, 2008, 416 days after the submission was received.
What is the product code of K071649?
The FDA product code is JIA – Enzymatic Methods, Galactose, a Class I (low risk) device regulated under 21 CFR 862.1310.