Panels › Clinical Chemistry › Product code JLX · Class 1
Radioimmunoassay, 17-Hydroxyprogesterone
Regulation 862.1395
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in JLX
| Company | 510(k)s | Recalls |
|---|---|---|
| Wallac OY | 5 | 0 |
| Diagnostic Products Corp. | 2 | 0 |
| Diagnostic Systems Laboratories, Inc. | 2 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 2 |
| Wien Laboratories, Inc. | 2 | 0 |
| Bio-Rad | 1 | 0 |
| DRG International, Inc. | 0 | 1 |
| Drg Intl., Inc. | 1 | 0 |
| Icn Biomedicals, Inc. | 1 | 0 |
| Neo-Genesis | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2010 | K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U Wallac OY | JLX |
| Apr 16, 2009 | K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY, FI | JLX |
| Jan 29, 2008 | K062534 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE Drg Intl., Inc. | JLX |
| Mar 13, 2007 | K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH Neo-Genesis | JLX |
| Jul 11, 2005 | K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT Wallac OY, FI | JLX |
| Sep 30, 2004 | K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY, FI | JLX |
| Sep 30, 2004 | K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT Wallac OY, FI | JLX |
| Feb 9, 1998 | K973350 | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST Bio-Rad | JLX |
| Mar 30, 1995 | K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE Neometrics, Inc. | JLX |
| Dec 28, 1994 | K940233 | NEOSCREEN ELISA HYDROXYPROGESTERONE Pantex | JLX |
| Nov 10, 1994 | K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) Diagnostic Systems Laboratories, Inc. | JLX |
| Jun 25, 1991 | K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT Pharmacia Diagnostics, Inc. | JLX |
| Jun 18, 1991 | K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT Pantex, Div. Bio-Analysis, Inc. | JLX |
| Sep 7, 1989 | K894265 | DSL 17A-OH PROGERSTERONE (DSL #6800) Diagnostic Systems Laboratories, Inc. | JLX |
| Feb 23, 1989 | K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA Icn Biomedicals, Inc. | JLX |
| Feb 11, 1988 | K874782 | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT Diagnostic Products Corp. | JLX |
| Apr 24, 1986 | K860335 | COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT Diagnostic Products Corp. | JLX |
| Feb 4, 1984 | K834246 | PROGESTERONE TEST SET 125I 17-OH Wien Laboratories, Inc. | JLX |
| Oct 21, 1977 | K771729 | 17-HYDROXYPROGESTERONE TEST SET Wien Laboratories, Inc. | JLX |
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