Product code JLX
- Device name
- Radioimmunoassay, 17-Hydroxyprogesterone
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1395
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100682 | GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001U | Wallac OY | 2010-07-23 |
| K081922 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2009-04-16 |
| K062534 | ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY 17-A-HYDROXYPROGESTERONE | Drg Intl., Inc. | 2008-01-29 |
| K060452 | ACCUWELL 17-ALPHA-HYDROXYPROESTERONE ENZYME IMMUNOASSAY WITH MODELS 6015XX-ECAH | Neo-Genesis | 2007-03-13 |
| K050960 | MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT | Wallac OY | 2005-07-11 |
| K042425 | AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2004-09-30 |
| K042424 | DELFIA NEONATAL 17A-OH-PROGESTERONE KIT | Wallac OY | 2004-09-30 |
| K973350 | BIO-RAD MICROPLATE 17-HYDROXYPROGESTERONE TEST | Bio-Rad | 1998-02-09 |
| K934178 | ACCUSCREEN 17-HYDROXYPROGESTERONE | Neometrics, Inc. | 1995-03-30 |
| K940233 | NEOSCREEN ELISA HYDROXYPROGESTERONE | Pantex | 1994-12-28 |
| K943148 | DSL ACTIVE 17A-OH PROGESTERONE RIA (DSL 5000) | Diagnostic Systems Laboratories, Inc. | 1994-11-10 |
| K912026 | DELFIA(R) 17 -OH-PROGESTERON KIT | Pharmacia Diagnostics, Inc. | 1991-06-25 |
| K911839 | NEONATAL BLOOD SPOT TEST 17-HYDROXPROG RADIO KIT | Pantex, Div. Bio-Analysis, Inc. | 1991-06-18 |
| K894265 | DSL 17A-OH PROGERSTERONE (DSL #6800) | Diagnostic Systems Laboratories, Inc. | 1989-09-07 |
| K885198 | 17-ALPHA-HYDROXYPROGESTERONE (17-OH-P) NEO. RIA | Icn Biomedicals, Inc. | 1989-02-23 |
| K874782 | COAT-A-COUNT NEONATAL 17-ALPHA HYDROXPROG RIA KIT | Diagnostic Products Corp. | 1988-02-11 |
| K860335 | COAT-A-COUNT 17-ALPHA-HYDROXYPROGESTERONE RIA KIT | Diagnostic Products Corp. | 1986-04-24 |
| K834246 | PROGESTERONE TEST SET 125I 17-OH | Wien Laboratories, Inc. | 1984-02-04 |
| K771729 | 17-HYDROXYPROGESTERONE TEST SET | Wien Laboratories, Inc. | 1977-10-21 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| B261CANP5400 | DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA | Diagnostics Biochem Canada Inc | 2026-04-27 |
| 00894175000770 | AccuDiag™ 17-alpha-OH Progesterone ELISA | Diagnostic Automation, Inc. | 2026-01-27 |
| 04048474012927 | 17 OH-Progesterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-18 |
| 00816870021164 | N-17-OHP AccuBind ELISA Test System - 96 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870021171 | N-17-OHP AccuBind ELISA Test System - 192 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870021188 | N-17-OHP AccuBind ELISA Test System - 480 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870021195 | N-17-OHP AccuBind ELISA Test System - 960 Wells | MONOBIND, INC. | 2024-09-13 |
| 00816870021201 | N-17-OHP AccuBind ELISA Test System - 1920 Wells | MONOBIND, INC. | 2024-09-13 |
| 04048474053333 | Progesterone (17-a-OH Progesterone) | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474031409 | Salivary 17-OH Progesterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474014297 | Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-08-26 |
| 00840239053336 | Progesterone (17-a-OH Progesterone) | DRG International Inc | 2023-08-26 |
| 00840239031402 | Salivary 17-OH Progesterone ELISA | DRG International Inc | 2023-08-26 |
| 00840239012920 | 17 OH Progesterone ELISA | DRG International Inc | 2023-08-23 |
| 00840239012937 | C-Peptide ELISA | DRG International Inc | 2023-08-23 |
| 00840239014290 | Progesterone, 17 a-Hydroxy- (Neonate) (MW) ELISA | DRG International Inc | 2023-08-23 |
| 00840239046659 | Progesterone, 17-a-OH | DRG International Inc | 2023-08-22 |
| 00817830023150 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 04049325033627 | 17-OH-Progesterone ELISA | IBL International GmbH | 2022-12-28 |
| 04049016138389 | 17-OH Progesterone ELISA | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| B261CANP3200 | DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA | Diagnostics Biochem Canada Inc | 2022-11-15 |
| B261CANP4000 | DBC 17α-Hydroxyprogesterone (17α-OHP) ELISA | Diagnostics Biochem Canada Inc | 2022-11-15 |
| 06925912718048 | iFlash-17α-OH-P | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 00404847431407 | Salivary 17-OH Progesterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847446654 | Progesterone, 17-a-OH ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847412925 | 17 OH-Progesterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847453331 | Progesterone (17-a-OH Progesterone) | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00725609000625 | SPOTCHECK | ASTORIA-PACIFIC, INC. | 2020-12-17 |
| B2422017OHUE01SLV0 | 17-alpha Hydroxy Progesterone ELISA (Saliva) | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-06-18 |
| B2422017OHUE010 | 17-alpha Hydroxy Progesterone ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2020-06-18 |