Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2560](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2560) → KHO — Fluorometer, For Clinical Use # KHO · Fluorometer, For Clinical Use _Clinical Chemistry · 21 CFR 862.2560 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO ## Overview - **Product Code:** KHO - **Device Name:** Fluorometer, For Clinical Use - **Regulation:** [21 CFR 862.2560](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2560) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A fluorometer for clinical use is a device intended to measure by fluorescence certain analytes. Fluorescence is the property of certain substances of radiating, when illuminated, a light of a different wavelength. This device is used in conjunction with certain materials to measure a variety of analytes. ## Classification Rationale Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9. ## Recent Cleared Devices (20 of 38) Showing 20 most recent of 38 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K112161](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K112161.md) | AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. | Radiometer Medical Aps | Jan 20, 2012 | SESE | | [K973547](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K973547.md) | TRIAGE STATMETER | Biosite Incorporated | Jan 13, 1998 | SESE | | [K971103](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K971103.md) | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Medics, Inc. | Jun 27, 1997 | SESE | | [K962919](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K962919.md) | VITROS IMMUNODIAGNOSTIC SYSTEM | Johnson & Johnson Clinical Diagnostics, Inc. | Oct 18, 1996 | SESE | | [K952719](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K952719.md) | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | Biocircuits Corp. | Nov 22, 1995 | SESE | | [K950415](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K950415.md) | FLUOROSCAN NEONATAL | Isolab, Inc. | Sep 5, 1995 | SESE | | [K935047](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K935047.md) | AUTO DELFIA | Wallac OY | May 23, 1994 | SESE | | [K930689](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K930689.md) | AUTOBEAD THYROID UPTAKE | Bio-Chem Laboratory Systems, Inc. | Nov 10, 1993 | SESE | | [K926131](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K926131.md) | OPUS MAGNUM ANALYZER | Pb Diagnostic Systems, Inc. | Jun 7, 1993 | SESE | | [K923021](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K923021.md) | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | Jul 21, 1992 | SESE | | [K920888](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K920888.md) | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Dynatech Laboratories, Inc. | Mar 19, 1992 | SESE | | [K913130](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K913130.md) | STRATUS IINTELLECT IMMUNOASSAY SYSTEM | Baxter Healthcare Corp | Sep 27, 1991 | SESE | | [K901674](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K901674.md) | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | May 2, 1990 | SESE | | [K895240](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K895240.md) | DELFIA PLATE FLUOROMETER 1232 | Pharmacia, Inc. | Oct 4, 1989 | SESE | | [K894159](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K894159.md) | OPUS IMMUNOASSAY SYSTEM | Pb Diagnostic Systems, Inc. | Aug 3, 1989 | SESE | | [K890908](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K890908.md) | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES | Baxter Healthcare Corp | Mar 24, 1989 | SESE | | [K872803](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K872803.md) | CYBERFLUOR 615 IMMUNOANALYZER | Cyberfluor, Inc. | Sep 2, 1987 | SESE | | [K871550](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K871550.md) | PFI-20 POLARIZING FLUORIMETER | The Perkin-Elmer Corp. | Jul 1, 1987 | SESE | | [K860309](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K860309.md) | HEMAFLUOR REAGENT KIT | Helena Laboratories | Jul 14, 1986 | SESE | | [K851984](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO/K851984.md) | LKB-WALLAC 1230 ARCUS FLUOROMETER | Lkb Instruments, Inc. | May 24, 1985 | SESE | ## Top Applicants - The Perkin-Elmer Corp. — 5 clearances - Abbott Laboratories — 2 clearances - Baxter Healthcare Corp — 2 clearances - Lkb Instruments, Inc. — 2 clearances - Miles Laboratories, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/KHO) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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