Product code CFT
- Device name
- Radioimmunoassay, Prolactin (Lactogen)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1625
- 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 |
|---|---|---|---|
| K971921 | PROLACTIN (PRL) HORMONE MICROPLATE ELISA | Monobind | 1997-06-24 |
| K970281 | VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS | Johnson & Johnson Clinical Diagnostics, Inc. | 1997-02-25 |
| K970188 | SEALITE SCIENCES, INC. AQUALITE PROLACTIN | Sealite Sciences, Inc. | 1997-02-20 |
| K964748 | ELECSYS PROLACTIN ASSAY | Boehringer Mannheim Corp. | 1997-01-21 |
| K960561 | DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 | Diagnostic Systems Laboratories, Inc. | 1996-04-26 |
| K960060 | DSL ACTIVE PROLACTIN IRMA | Diagnostic Systems Laboratories, Inc. | 1996-02-29 |
| K954680 | ACCESS PROLACTIN ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-10-20 |
| K953656 | ABBOTT IMX PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-10-03 |
| K953657 | ABBOTT AXSYM PROLACTIN(MODIFICATION) | Abbott Mfg., Inc. | 1995-09-25 |
| K944698 | AURAFLEX PROLACTIN 200 TEST PACK, CALIBRATOR PACK, DILVENT 1 | Organon Teknika Corp. | 1995-03-21 |
| K943811 | ENZYME-LINKED FLUORESCENT IMMUNOASSAY | Biomerieux Vitek, Inc. | 1994-11-02 |
| K935675 | AXSYM PROLACTIN | Abbott Laboratories | 1994-06-21 |
| K941220 | DUPONT ACA PLUS PROLACTIN (PROL) METHOD | Dupont Medical Products | 1994-06-03 |
| K941175 | ACCESS PROLACTIN | Bio-Rad Laboratories, Inc. | 1994-06-02 |
| K930305 | COBAS CORE PROLACTIN EIA | Roche Diagnostic Systems, Inc. | 1993-08-19 |
| K926386 | VISTA PROLACTIN ASSAY | Syva Co. | 1993-03-29 |
| K925846 | IMMULITE PROLACTIN | Diagnostic Products Corp. | 1993-03-05 |
| K922715 | IMMUCHEM PRL-MW ELISA | Icn Biomedicals, Inc. | 1992-10-05 |
| K922170 | AMERLITE PROLACTIN-30 ASSAY | Eastman Kodak Company | 1992-09-02 |
| K920921 | ELISA TUBE PROLACTIN TEST KIT | Bio Clinic Co. | 1992-04-08 |
| K920345 | PROLACTIN ENZYME IMMUNOASSAY TEST KIT (MODIFIED) | Medix Biotech, Inc. | 1992-03-18 |
| K914135 | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 | Amersham Corp. | 1992-02-18 |
| K914107 | PROLACTIN IRMA IMMUNOMAG | Pantex, Div. Bio-Analysis, Inc. | 1991-09-30 |
| K913280 | OPUS(R) PROLACTIN TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-08-16 |
| K904714 | CIBA CORNING ACS PROLACTIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1990-11-07 |
| K904483 | ELEGANCE PROLACTIN ELISA | Bioclone Australia Pty , Ltd. | 1990-11-05 |
| K904458 | LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION | London Diagnostics, Inc. | 1990-10-12 |
| K902698 | AFFINITY PROLACTIN TEST SYSTEM | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1990-07-19 |
| K901673 | PROLACTIN (LACTOGEN) TEST SYSTEM | Baxter Healthcare Corp | 1990-06-12 |
| K901578 | COAT-A-COUNT PROLACTIN IRMA #:IKPR1, IKPR2 | Diagnostic Products Corp. | 1990-04-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850049545433 | AccuDiag™ Prolactin (PRL) ELISA | Diagnostic Automation, Inc. | 2026-01-30 |
| 14560189216324 | CL AIA-PACK Prolactin II TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 24560189216321 | CL AIA-PACK Prolactin II TEST CUP | TOSOH CORPORATION | 2025-09-01 |
| 04048474012910 | Prolactin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2024-11-22 |
| 07613336218426 | Elecsys Prolactin II | Roche Diagnostics GmbH | 2024-10-08 |
| 04048474053692 | Prolactin | DRG Instruments Gesellschaft mit beschränkter Haftung | 2023-09-01 |
| 00840239053695 | Prolactin | DRG International Inc | 2023-08-26 |
| 00840239012913 | Prolactin ELISA | DRG International Inc | 2023-08-23 |
| B652IB59110 | Prolactin ELISA | IBL America | 2023-06-08 |
| B24220PROHUE010 | Prolactin ELISA | AMERICAN LABORATORY PRODUCTS COMPANY, LTD. | 2023-02-22 |
| B261CANPRL41000 | DBC Prolactin ELISA | Diagnostics Biochem Canada Inc | 2022-11-10 |
| 06925912718772 | iFlash-Prolactin | Shenzhen YHLO Biotech Co., Ltd. | 2022-10-26 |
| 10758750034321 | VITROS | ORTHO CLINICAL DIAGNOSTICS | 2022-10-24 |
| 15099590575229 | ACCESS PROLACTIN | Beckman Coulter, Inc. | 2021-09-03 |
| 15099590232269 | ACCESS PROLACTIN CALIBRATORS | Beckman Coulter, Inc. | 2021-09-03 |
| 00840239017864 | Prolactin ELISA | DRG International Inc | 2021-06-07 |
| 00404847453690 | Prolactin | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00404847412918 | Prolactin ELISA | DRG Instruments Gesellschaft mit beschränkter Haftung | 2021-06-07 |
| 00630414177274 | ADVIA Centaur® PRL | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414177267 | ADVIA Centaur® PRL | Siemens Healthcare Diagnostics Inc. | 2020-09-24 |
| 00630414167503 | IMMULITE 2000 Prolactin Kit Domestic 600T | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414167497 | IMMULITE 2000 Prolactin Kit Domestic 200T | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD | 2020-09-24 |
| 00630414293721 | Atellica IM PRL | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 14560189210834 | ST AIA-PACK PRL | TOSOH CORPORATION | 2019-07-25 |
| 24560189210831 | ST AIA-PACK PRL | TOSOH CORPORATION | 2019-07-25 |
| 14560189211824 | AIA-PACK PRL CALIBRATOR SET | TOSOH CORPORATION | 2019-07-25 |
| 04560189211827 | AIA-PACK PRL CALIBRATOR SET | TOSOH CORPORATION | 2019-07-25 |
| 14560189211817 | AIA-PACK PRL SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 04560189211810 | AIA-PACK PRL SAMPLE DILUTING SOLUTION | TOSOH CORPORATION | 2019-07-24 |
| 04015630940097 | Elecsys Prolactin II | Roche Diagnostics GmbH | 2017-04-14 |