Product Code: KHO
FDA class 1
21 CFR 862.2560
Fluorometer, For Clinical Use
Clinical Chemistry
Clinical Fluorometer is a laboratory instrument used in clinical chemistry that measures the fluorescence emitted by chemical compounds in a sample when excited by light of a specific wavelength, enabling quantitative analysis of fluorescent analytes such as drugs, metabolites, and other biochemical substances in clinical specimens. It is classified as FDA Class 1, the lowest risk category, subject to general controls only, meaning it does not require premarket notification or approval. The product code is KHO, regulated under 21 CFR 862.2560, within the Clinical Chemistry medical specialty.
510(k)s
38
FEI Numbers
57
Registration Numbers
57
Unique Applicants
28
Years Active
35
Basic Information
- Product Code
- KHO
- Device Class
- FDA class 1
- Regulation Number
- 862.2560
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 38 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K112161 | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. | Jan 20, 2012 | Substantially Equivalent | RADIOMETER MEDICAL APS |
| K973547 | TRIAGE STATMETER | Jan 13, 1998 | Substantially Equivalent | BIOSITE INCORPORATED |
| K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Jun 27, 1997 | Substantially Equivalent | TOSOH MEDICS, INC. |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | Oct 18, 1996 | Substantially Equivalent | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
| K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | Nov 22, 1995 | Substantially Equivalent | BIOCIRCUITS CORP. |
| K950415 | FLUOROSCAN NEONATAL | Sep 05, 1995 | Substantially Equivalent | ISOLAB, INC. |
| K935047 | AUTO DELFIA | May 23, 1994 | Substantially Equivalent | WALLAC OY |
| K930689 | AUTOBEAD THYROID UPTAKE | Nov 10, 1993 | Substantially Equivalent | BIO-CHEM LABORATORY SYSTEMS, INC. |
| K926131 | OPUS MAGNUM ANALYZER | Jun 07, 1993 | Substantially Equivalent | PB DIAGNOSTIC SYSTEMS, INC. |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Jul 21, 1992 | Substantially Equivalent | TOSOH CORP. |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Mar 19, 1992 | Substantially Equivalent | DYNATECH LABORATORIES, INC. |
| K913130 | STRATUS IINTELLECT IMMUNOASSAY SYSTEM | Sep 27, 1991 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | May 02, 1990 | Substantially Equivalent | TOSOH CORP. |
| K895240 | DELFIA PLATE FLUOROMETER 1232 | Oct 04, 1989 | Substantially Equivalent | PHARMACIA, INC. |
| K894159 | OPUS IMMUNOASSAY SYSTEM | Aug 03, 1989 | Substantially Equivalent | PB DIAGNOSTIC SYSTEMS, INC. |
| K890908 | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES | Mar 24, 1989 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K872803 | CYBERFLUOR 615 IMMUNOANALYZER | Sep 02, 1987 | Substantially Equivalent | CYBERFLUOR, INC. |
| K871550 | PFI-20 POLARIZING FLUORIMETER | Jul 01, 1987 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K860309 | HEMAFLUOR REAGENT KIT | Jul 14, 1986 | Substantially Equivalent | HELENA LABORATORIES |
| K851984 | LKB-WALLAC 1230 ARCUS FLUOROMETER | May 24, 1985 | Substantially Equivalent | LKB INSTRUMENTS, INC. |
| K830624 | FLUOROMETER, GENERAL USE | Apr 05, 1983 | Substantially Equivalent | ABBOTT DIAGNOSTICS |
| K822942 | INNOTRON FLUORIMETER SERIES ONE-10 | Dec 09, 1982 | Substantially Equivalent | INNOTRON OF OREGON, INC. |
| K823112 | CLINISTAT TDA SERIES | Nov 29, 1982 | Substantially Equivalent | MILES LABORATORIES, INC. |
| K822772 | MICROFLUOR READER | Oct 27, 1982 | Substantially Equivalent | DYNATECH CORP. |
| K822701 | FLUOROSTAT FLUOROMETER | Oct 08, 1982 | Substantially Equivalent | MILES LABORATORIES, INC. |
| K813540 | A FLUOROMETER | Dec 31, 1981 | Substantially Equivalent | AMERICAN DIAGNOSTIC CORP. |
| K813146 | SYVA ADVANCE TM FLUOROMETER | Nov 27, 1981 | Substantially Equivalent | SYVA CO. |
| K811019 | LKB 4460 FLUORIMETER | Apr 29, 1981 | Substantially Equivalent | LKB INSTRUMENTS, INC. |
| K802579 | CYBREX TM FPQ FLUORESCENE POLARIZATION | Nov 12, 1980 | Substantially Equivalent | ABBOTT LABORATORIES |
| K791329 | FLUOROMATIC ANALYZER AND AUTOSAMPLER | Jul 30, 1979 | Substantially Equivalent | BIO-RAD |
| K790236 | SPECTROPHOTOMETER MODEL 650-40 | Mar 15, 1979 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K790235 | SPECTROPHOTOMETER MODEL 3000 | Mar 15, 1979 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K780242 | SPECTROPHOTOMETER, FLUORESCENCE M.650-10 | Mar 27, 1978 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
| K780362 | SPECTROFLUOROMETER SF-330 | Mar 22, 1978 | Substantially Equivalent | VARIAN ASSOC., INC. |
| K780122 | HTSH RIA | Feb 03, 1978 | Substantially Equivalent | ABBOTT LABORATORIES |
| K780031 | FLUORESCENCE DETECTOR MODEL 420 | Jan 20, 1978 | Substantially Equivalent | WATERS ASSOC., INC. |
| K760506 | HEMAFLOUR ZP | Oct 28, 1976 | Substantially Equivalent | BUCHLER INSTRUMENTS, INC. |
| K760261 | DETECTOR, MODEL LC-100 FLUORESCENCE | Sep 27, 1976 | Substantially Equivalent | THE PERKIN-ELMER CORP. |
FEI Numbers
This FDA classification entry is associated with 57 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 57 registration numbers. Click on an entry to view related FDA registrations.