Product code KHO
- Device name
- Fluorometer, For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2560
- 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 |
|---|---|---|---|
| K112161 | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. | Radiometer Medical Aps | 2012-01-20 |
| K973547 | TRIAGE STATMETER | Biosite Incorporated | 1998-01-13 |
| K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Medics, Inc. | 1997-06-27 |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-10-18 |
| K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | Biocircuits Corp. | 1995-11-22 |
| K950415 | FLUOROSCAN NEONATAL | Isolab, Inc. | 1995-09-05 |
| K935047 | AUTO DELFIA | Wallac OY | 1994-05-23 |
| K930689 | AUTOBEAD THYROID UPTAKE | Bio-Chem Laboratory Systems, Inc. | 1993-11-10 |
| K926131 | OPUS MAGNUM ANALYZER | Pb Diagnostic Systems, Inc. | 1993-06-07 |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | 1992-07-21 |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Dynatech Laboratories, Inc. | 1992-03-19 |
| K913130 | STRATUS IINTELLECT IMMUNOASSAY SYSTEM | Baxter Healthcare Corp | 1991-09-27 |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | 1990-05-02 |
| K895240 | DELFIA PLATE FLUOROMETER 1232 | Pharmacia, Inc. | 1989-10-04 |
| K894159 | OPUS IMMUNOASSAY SYSTEM | Pb Diagnostic Systems, Inc. | 1989-08-03 |
| K890908 | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES | Baxter Healthcare Corp | 1989-03-24 |
| K872803 | CYBERFLUOR 615 IMMUNOANALYZER | Cyberfluor, Inc. | 1987-09-02 |
| K871550 | PFI-20 POLARIZING FLUORIMETER | The Perkin-Elmer Corp. | 1987-07-01 |
| K860309 | HEMAFLUOR REAGENT KIT | Helena Laboratories | 1986-07-14 |
| K851984 | LKB-WALLAC 1230 ARCUS FLUOROMETER | Lkb Instruments, Inc. | 1985-05-24 |
| K830624 | FLUOROMETER, GENERAL USE | Abbott Diagnostics | 1983-04-05 |
| K822942 | INNOTRON FLUORIMETER SERIES ONE-10 | Innotron of Oregon, Inc. | 1982-12-09 |
| K823112 | CLINISTAT TDA SERIES | Miles Laboratories, Inc. | 1982-11-29 |
| K822772 | MICROFLUOR READER | Dynatech Corp. | 1982-10-27 |
| K822701 | FLUOROSTAT FLUOROMETER | Miles Laboratories, Inc. | 1982-10-08 |
| K813540 | A FLUOROMETER | American Diagnostic Corp. | 1981-12-31 |
| K813146 | SYVA ADVANCE TM FLUOROMETER | Syva Co. | 1981-11-27 |
| K811019 | LKB 4460 FLUORIMETER | Lkb Instruments, Inc. | 1981-04-29 |
| K802579 | CYBREX TM FPQ FLUORESCENE POLARIZATION | Abbott Laboratories | 1980-11-12 |
| K791329 | FLUOROMATIC ANALYZER AND AUTOSAMPLER | Bio-Rad | 1979-07-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10850076346017 | Healgen | HEALGEN LIFE SCIENCE, LLC | 2026-02-06 |
| 00850076346010 | Healgen | HEALGEN LIFE SCIENCE, LLC | 2026-02-06 |
| 05430003908761 | SEEKER® | Lacar MDX Technologies | 2026-01-15 |
| 07649996894014 | abioSCOPE | Abionic SA | 2025-02-18 |
| 06974849369397 | Macro & Micro-Test Fluorescence Immunoassay Analyzer | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2024-09-19 |
| 06974849369380 | Macro & Micro-Test Fluorescence Immunoassay Analyzer | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2024-09-19 |
| 08809317541259 | FREND System | NanoEnTek, Inc. | 2024-06-30 |
| 08800066300104 | ASFA® SCANNER | MBD CO., Ltd. | 2023-11-21 |
| 06974521002246 | Superbio Immunofluorescence Analyzer | Shenzhen Superbio Technology Co., Ltd. | 2023-03-22 |
| 06974521006626 | Bioeasy Immunofluorescence Analyzer | Shenzhen Superbio Technology Co., Ltd. | 2023-03-22 |
| 00817302022339 | Carolina Liquid Chemistries Corp. Immunofluorescence Analyzer RYAN | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2023-03-10 |
| 06974849369298 | Immunofluorescence Reader | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. | 2022-12-06 |
| 09120052070521 | INFINITE 200 PRO | Tecan Austria GmbH | 2021-06-22 |
| 06970136030100 | NA | Guangzhou Labsim Biotech Co., Ltd | 2020-05-20 |
| 06970136030216 | NA | Guangzhou Labsim Biotech Co., Ltd | 2020-05-20 |
| 04560189282896 | AUTOMATED ENZYME IMMUNOASSAY SYSTEM AIA-360 | TOSOH CORPORATION | 2019-09-02 |
| 04560189283992 | AUTOMATED ENZYME IMMUNOASSAY ANALYZER AIA-900 | TOSOH CORPORATION | 2019-09-02 |
| 04560189284005 | 9tray Sorter | TOSOH CORPORATION | 2019-09-02 |
| 04560189284012 | 19tray Sorter | TOSOH CORPORATION | 2019-09-02 |
| 30014613338109 | Triage | QUIDEL CARDIOVASCULAR INC. | 2019-08-02 |
| 30014613337164 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 30014613337157 | Triage | QUIDEL CARDIOVASCULAR INC. | 2018-11-01 |
| 08806133070437 | Boditech TSH Calibrator | Boditech Med Inc. | 2018-10-17 |
| 08806133060353 | Boditech TSH Control | Boditech Med Inc. | 2018-10-17 |
| 08809317540207 | FREND System | NanoEnTek, Inc. | 2018-05-04 |
| 08806133010082 | AFIAS-6/VB Analyzer | Boditech Med Inc. | 2017-11-06 |
| 08806133005279 | AFIAS TSH-VB | Boditech Med Inc. | 2017-11-06 |
| 10627966005237 | RAMP® 200 CM Control Module | Response Biomedical Corp | 2017-08-31 |
| 10627966005244 | RAMP® 200 TM Test Module | Response Biomedical Corp | 2017-08-31 |
| 10627966005220 | RAMP® 1 Clinical Reader System | Response Biomedical Corp | 2017-08-31 |