GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001U
FDA 510(k) K100682 · Wallac OY
510(k) numberK100682
Submission
- Device name
- GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001U
- Applicant
- Wallac OY
Indianapolis, IN, US - Received
- March 10, 2010
- Decision date
- July 23, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JLX – Radioimmunoassay, 17-Hydroxyprogesterone
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1395
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JLX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081922 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Traditional | Wallac OY | 04/16/2009SE |
| K062534 | Enzyme Immunoassay for the Detection of Salivary 17-A-HYDROXYPROGESTERONEJLX · Traditional | Drg Intl., Inc. | 01/29/2008SE |
| K060452 | Accuwell 17-ALPHA-HYDROXYPROESTERONE Enzyme Immunoassay with Models 6015XX-ECAHJLX · Abbreviated | Neo-Genesis | 03/13/2007SE |
| K050960 | Modification to: Autodelfia Neonatal 17A-OH-PROGESTERONE L KitJLX · Special | Wallac OY | 07/11/2005SE |
| K042425 | Autodelfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | Wallac OY | 09/30/2004SE |
| K042424 | Delfia Neonatal 17A-OH-PROGESTERONE KitJLX · Special | Wallac OY | 09/30/2004SE |
| K973350 | Bio-Rad Microplate 17-HYDROXYPROGESTERONE TestJLX · Traditional | Bio-Rad | 02/09/1998SE |
| K934178 | Accuscreen 17-HYDROXYPROGESTERONEJLX · Traditional | Neometrics, Inc. | 03/30/1995SE |
| K940233 | Neoscreen Elisa HydroxyprogesteroneJLX · Traditional | Pantex | 12/28/1994SE |
| K943148 | DSL Active 17A-OH Progesterone Ria (DSL 5000)JLX · Traditional | Diagnostic Systems Laboratories, Inc. | 11/10/1994SE |
More from Diagnostic Systems Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131284 | GSP Neonatal Biotinidase KitNAK · Traditional | 11/14/2013SE |
| 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 17A-OH-PROGESTERONE Kit Model: 3305-001U cleared by the FDA?
GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001U (K100682) received a 510(k) decision of Substantially Equivalent on July 23, 2010, 135 days after the submission was received.
What is the product code of K100682?
The FDA product code is JLX – Radioimmunoassay, 17-Hydroxyprogesterone, a Class I (low risk) device regulated under 21 CFR 862.1395.