17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. Ria
FDA 510(k) K885198 · Icn Biomedicals, Inc.
510(k) numberK885198
Submission
- Device name
- 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. Ria
- Applicant
- Icn Biomedicals, Inc.
Carson, CA, US - Received
- December 16, 1988
- Decision date
- February 23, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K940233 | Neoscreen Elisa HydroxyprogesteroneJLX · Traditional | Pantex | 12/28/1994SE |
More from Pantex
| 510(k) | Device | Decision |
|---|---|---|
| K030211 | Rapid Barbiturate Test Strip and Test Card, Models 7015 and 7016DKX · Traditional | 06/13/2003SE |
| K023252 | Rapid Methadone Test Strip, Model 7019 & Rapid Methadone Test Card, Model 7020DJR · Traditional | 11/22/2002SE |
| K926106 | Immuchem Phe-Mw EaJNB · Traditional | 02/08/1995SE |
| K922944 | Immuchem Lh-Mw ElisaCEP · Traditional | 02/02/1993SE |
| K922715 | Immuchem Prl-Mw ElisaCFT · Traditional | 10/05/1992SE |
| K922376 | Icn Biomedicals Immuchem(Tm) Fsh-Mw Elisa KitCGJ · Traditional | 10/05/1992SE |
| K920442 | Immuchem Tsh-Mw ElisaJLW · Traditional | 03/18/1992SE |
| K913963 | Immuchem Neonatal Tsh-Mp ElisaJLW · Traditional | 12/13/1991SE |
| K902445 | Lympho Sep(Tm)JCF · Traditional | 08/22/1990SE |
| K881005 | Immuchem Human Chorionic Gonadotropin Hormone HCGJHI · Traditional | 05/27/1988SE |
Questions and answers
When was 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. Ria cleared by the FDA?
17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) Neo. Ria (K885198) received a 510(k) decision of Substantially Equivalent on February 23, 1989, 69 days after the submission was received.
What is the product code of K885198?
The FDA product code is JLX – Radioimmunoassay, 17-Hydroxyprogesterone, a Class I (low risk) device regulated under 21 CFR 862.1395.