Neoscreen Elisa Hydroxyprogesterone
FDA 510(k) K940233 · Pantex
510(k) numberK940233
Submission
- Device name
- Neoscreen Elisa Hydroxyprogesterone
- Applicant
- Pantex
Santa Monica, CA, US - Received
- January 18, 1994
- Decision date
- December 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K100682 | GSP Neonatal 17A-OH-PROGESTERONE Kit Model: 3305-001UJLX · Traditional | Wallac OY | 07/23/2010SE |
| 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 |
| K943148 | DSL Active 17A-OH Progesterone Ria (DSL 5000)JLX · Traditional | Diagnostic Systems Laboratories, Inc. | 11/10/1994SE |
Questions and answers
When was Neoscreen Elisa Hydroxyprogesterone cleared by the FDA?
Neoscreen Elisa Hydroxyprogesterone (K940233) received a 510(k) decision of Substantially Equivalent on December 28, 1994, 344 days after the submission was received.
What is the product code of K940233?
The FDA product code is JLX – Radioimmunoassay, 17-Hydroxyprogesterone, a Class I (low risk) device regulated under 21 CFR 862.1395.