JLX — Radioimmunoassay, 17-Hydroxyprogesterone Class I
FDA product code JLX covers "Radioimmunoassay, 17-Hydroxyprogesterone", a Class I medical device regulated under 21 CFR 862.1395. Submissions are reviewed by the Clinical Chemistry panel. At least 19 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JLX
- Device Class
- Class I
- Regulation Number
- 862.1395
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K100682 | wallac | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | July 23, 2010 |
| K081922 | wallac | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | April 16, 2009 |
| K062534 | drg intl | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | January 29, 2008 |
| K060452 | neo-genesis | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | March 13, 2007 |
| K050960 | wallac | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | July 11, 2005 |
| K042425 | wallac | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | September 30, 2004 |
| K042424 | wallac | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | September 30, 2004 |
| K973350 | bio-rad | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST | February 9, 1998 |
| K934178 | neometrics | ACCUSCREEN 17-HYDROXYPROGESTERONE | March 30, 1995 |
| K940233 | pantex | NEOSCREEN ELISA HYDROXYPROGESTERONE | December 28, 1994 |
| K943148 | diagnostic systems laboratories | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | November 10, 1994 |
| K912026 | pharmacia diagnostics | DELFIA(R) 17 -OH-PROGESTERON KIT | June 25, 1991 |
| K911839 | pantex, div. bio-analysis | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | June 18, 1991 |
| K894265 | diagnostic systems laboratories | DSL 17A-OH PROGERSTERONE (DSL #6800) | September 7, 1989 |
| K885198 | icn biomedicals | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | February 23, 1989 |
| K874782 | diagnostic products | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT | February 11, 1988 |
| K860335 | diagnostic products | COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT | April 24, 1986 |
| K834246 | wien laboratories | PROGESTERONE TEST SET 125I 17-OH | February 4, 1984 |
| K771729 | wien laboratories | 17-HYDROXYPROGESTERONE TEST SET | October 21, 1977 |