Product code JLS
- Device name
- Radioimmunoassay, Progesterone
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1620
- 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 |
|---|---|---|---|
| K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA | Ibl GmbH | 2004-07-22 |
| K973898 | PROGESTERONE ELISA | Kmi Diagnostics, Inc. | 1997-11-13 |
| K972133 | VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070) | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-06-24 |
| K971725 | OPUS PROGESTERONE | Behring Diagnostics, Inc. | 1997-06-18 |
| K964841 | ELECSYS PROGESTERONE ASSAY | Boehringer Mannheim Corp. | 1997-03-24 |
| K965084 | VIDAS PROESTERONE (PRG) (30 409) | bioMerieux, Inc. | 1997-01-09 |
| K955025 | AXSYM PROGESTERONE | Abbott Laboratories | 1996-03-07 |
| K955769 | ACCESS PROGESTERONE ASSAY | Bio-Rad Laboratories, Inc. | 1996-02-05 |
| K952075 | PROGESTERONE ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-BITRO DIAGNOSTIC SYSTEM | Bayer Corp. | 1995-06-13 |
| K951630 | AURAFLEX PROGESTERONE 150TEST PACK | Organon Teknika Corp. | 1995-05-08 |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Diagnostics, Inc. | 1995-04-11 |
| K944211 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | 1994-12-19 |
| K935138 | IMMULITE PROGESTERONE | Diagnostic Products Corp. | 1994-01-11 |
| K933128 | SYNELISA PROGESTERONE | Elias U.S.A., Inc. | 1993-11-05 |
| K933269 | AIA-PACK(R) PROG ASSAY | Tosoh Medics, Inc. | 1993-10-22 |
| K931228 | PROGESTERONE RADIOIMMUNOASSAY KIT | Immunotech Corp. | 1993-10-22 |
| K933635 | STRATUS PROGESTERONE FLOUROMETRIC IMMUNOASSAY | Baxter Diagnostics, Inc. | 1993-10-08 |
| K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-08-02 |
| K923410 | FIAGEN PROGESTERONE | Cyberfluor, Inc. | 1992-12-03 |
| K920230 | AFFINITY PRG | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1992-02-18 |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | Serono-Baker Diagnostics, Inc. | 1991-10-23 |
| K911512 | MILENIA PROGESTERONE | Diagnostic Products Corp. | 1991-05-22 |
| K910683 | ENZYMUN-TEST PROGESTERONE | Boehringer Mannheim Corp. | 1991-04-08 |
| K894049 | IMMUNOCOAT PROGESTERONE RADIOIMMUNOASSAY KIT | Pantex, Div. Bio-Analysis, Inc. | 1989-09-08 |
| K890836 | RIA-GNOST PROGESTERONE | Cambridge Medical Technology | 1989-03-16 |
| K890428 | DELFIA PROGESTERONE KIT | Pharmacia, Inc. | 1989-02-23 |
| K884794 | PROGESTERONE SEROZYME IMMUNOENZYMETRIC ASSAY | Serono-Baker Diagnostics, Inc. | 1989-02-02 |
| K884100 | AMERLITE PROGESTERONE ASSAY, LAN.0079/2079 240/144 | Amersham Corp. | 1988-11-10 |
| K880934 | MODIFIED AMERLEX-M PROGESTERONE RADIOIMMUNO. KIT | Amersham Corp. | 1988-04-18 |
| K873431 | PROGESTERONE MAIA RADIOIMMUNO ASSAY KIT MAG SLD PH | Serono Diagnostics, Inc. | 1987-10-20 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00894175000800 | AccuDiag™ Progesterone ELISA | Diagnostic Automation, Inc. | 2026-01-30 |
| 14562185399667 | CL AIA-PACK Progesterone TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 24562185399664 | CL AIA-PACK Progesterone TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 10758750035366 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2025-05-20 |
| 20758750035363 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2025-05-20 |
| 04048474015614 | Progesterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 04048474046632 | Progesterone (serum) ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-21 |
| 07613336218419 | Elecsys Progesterone III | Roche Diagnostics GmbH | 2024-05-30 |
| 15099590752705 | Access Progesterone II Sample Diluent | Beckman Coulter, Inc. | 2024-03-01 |
| 15099590752682 | Access Progesterone II | Beckman Coulter, Inc. | 2024-03-01 |
| 04048474059113 | Salivary Progesterone HS ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474053685 | Progesterone | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 04048474029314 | Salivary Progesterone ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 00840239059116 | Salivary Progesterone HS ELISA | DRG International Inc | 2023-08-26 |
| 00840239053688 | Progesterone | DRG International Inc | 2023-08-26 |
| 00840239029317 | Salivary Progesterone ELISA | DRG International Inc | 2023-08-26 |
| 00840239015617 | Progesterone ELISA | DRG International Inc | 2023-08-23 |
| 00840239046635 | Progesterone (serum) | DRG International Inc | 2023-08-22 |
| 00817830023198 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00817830023181 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00817830023167 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00817830023174 | MP Biomedicals LLC | Mp Biomedicals, LLC | 2023-08-02 |
| 00850039602733 | Pantex | Pantex | 2023-03-17 |
| 00630414293714 | Atellica IM PRGE | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 03573026156954 | VIDAS® Progesterone | BIOMERIEUX SA | 2019-07-26 |
| 04560189213463 | ST AIA-PACK PROG III SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-11 |
| 04560189213425 | ST-AIA-PACK PROG II SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-11 |
| 14560189213439 | ST AIA-PACK PROG III | TOSOH CORPORATION | 2019-07-11 |
| 04015630939770 | Elecsys Progesterone III | Roche Diagnostics GmbH | 2017-04-14 |
| 00610586016434 | Deltec | ICU MEDICAL, INC. | 2015-09-01 |