Progesterone Test Set 125I 17-OH
FDA 510(k) K834246 · Wien Laboratories, Inc.
510(k) numberK834246
Submission
- Device name
- Progesterone Test Set 125I 17-OH
- Applicant
- Wien Laboratories, Inc.
Mchenry, IL, US - Received
- December 7, 1983
- Decision date
- February 4, 1984
- 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 |
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|---|---|---|
| K912850 | SHBGCDZ · Traditional | 08/12/1991SE |
| K832452 | Androstenedione Test Set 125ICIZ · Traditional | 09/12/1983SE |
| K823200 | 125 I-Dehydroepiandrosterone SulfateJKC · Traditional | 11/29/1982SE |
| K821653 | Protriptyline Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K821652 | Doxepin Tri-Cy Test SetLFG · Traditional | 06/14/1982SE |
| K802728 | 125I-TESTOSTERONE Test SetCDZ · Traditional | 12/11/1980SE |
| K792041 | Dhea-Sulfate Test SetJKC · Traditional | 10/30/1979SE |
| K781834 | Test Set, 125 I-DigoxinDNL · Traditional | 01/03/1979SE |
| K781599 | I-Estriol Test SetCGI · Traditional | 10/17/1978SE |
| K772306 | 125I Digoxin Test SetDPB · Traditional | 12/22/1977SE |
Questions and answers
When was Progesterone Test Set 125I 17-OH cleared by the FDA?
Progesterone Test Set 125I 17-OH (K834246) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 59 days after the submission was received.
What is the product code of K834246?
The FDA product code is JLX – Radioimmunoassay, 17-Hydroxyprogesterone, a Class I (low risk) device regulated under 21 CFR 862.1395.