FDA Product Code
FDA Product Code JLX — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1395
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | Wallac OY | 2010-07-23 | Traditional | PDF ↗ |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2009-04-16 | Traditional | PDF ↗ |
| K062534 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | Drg Intl., Inc. | 2008-01-29 | Traditional | PDF ↗ |
| K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | Neo-Genesis | 2007-03-13 | Abbreviated | PDF ↗ |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | Wallac OY | 2005-07-11 | Special | PDF ↗ |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2004-09-30 | Special | PDF ↗ |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2004-09-30 | Special | PDF ↗ |
| K973350 | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST | Bio-Rad | 1998-02-09 | Traditional | PDF ↗ |
| K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE | Neometrics, Inc. | 1995-03-30 | Traditional | PDF ↗ |
| K940233 | NEOSCREEN ELISA HYDROXYPROGESTERONE | Pantex | 1994-12-28 | Traditional | PDF ↗ |
| K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | Diagnostic Systems Laboratories, Inc. | 1994-11-10 | Traditional | PDF ↗ |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | Pharmacia Diagnostics, Inc. | 1991-06-25 | Traditional | PDF ↗ |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-06-18 | Traditional | PDF ↗ |
| K894265 | DSL 17A-OH PROGERSTERONE (DSL #6800) | Diagnostic Systems Laboratories, Inc. | 1989-09-07 | Traditional | PDF ↗ |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Icn Biomedicals, Inc. | 1989-02-23 | Traditional | PDF ↗ |
| K874782 | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT | Diagnostic Products Corp. | 1988-02-11 | Traditional | PDF ↗ |
| K860335 | COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT | Diagnostic Products Corp. | 1986-04-24 | Traditional | PDF ↗ |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Wien Laboratories, Inc. | 1984-02-04 | Traditional | PDF ↗ |
| K771729 | 17-HYDROXYPROGESTERONE TEST SET | Wien Laboratories, Inc. | 1977-10-21 | Traditional | PDF ↗ |
Product code JLX · Class I · Clinical Chemistry. Data: openFDA.