KHO · Fluorometer, For Clinical Use
Clinical Chemistry · 21 CFR 862.2560 · Class 1
Overview
| Product Code | KHO |
|---|---|
| Device Name | Fluorometer, For Clinical Use |
| Regulation | 21 CFR 862.2560 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
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 | 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 | TRIAGE STATMETER | Biosite Incorporated | Jan 13, 1998 | SESE |
| K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Medics, Inc. | Jun 27, 1997 | SESE |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | Johnson & Johnson Clinical Diagnostics, Inc. | Oct 18, 1996 | SESE |
| K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | Biocircuits Corp. | Nov 22, 1995 | SESE |
| K950415 | FLUOROSCAN NEONATAL | Isolab, Inc. | Sep 5, 1995 | SESE |
| K935047 | AUTO DELFIA | Wallac OY | May 23, 1994 | SESE |
| K930689 | AUTOBEAD THYROID UPTAKE | Bio-Chem Laboratory Systems, Inc. | Nov 10, 1993 | SESE |
| K926131 | OPUS MAGNUM ANALYZER | Pb Diagnostic Systems, Inc. | Jun 7, 1993 | SESE |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | Jul 21, 1992 | SESE |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Dynatech Laboratories, Inc. | Mar 19, 1992 | SESE |
| K913130 | STRATUS IINTELLECT IMMUNOASSAY SYSTEM | Baxter Healthcare Corp | Sep 27, 1991 | SESE |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | May 2, 1990 | SESE |
| K895240 | DELFIA PLATE FLUOROMETER 1232 | Pharmacia, Inc. | Oct 4, 1989 | SESE |
| K894159 | OPUS IMMUNOASSAY SYSTEM | Pb Diagnostic Systems, Inc. | Aug 3, 1989 | SESE |
| K890908 | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES | Baxter Healthcare Corp | Mar 24, 1989 | SESE |
| K872803 | CYBERFLUOR 615 IMMUNOANALYZER | Cyberfluor, Inc. | Sep 2, 1987 | SESE |
| K871550 | PFI-20 POLARIZING FLUORIMETER | The Perkin-Elmer Corp. | Jul 1, 1987 | SESE |
| K860309 | HEMAFLUOR REAGENT KIT | Helena Laboratories | Jul 14, 1986 | SESE |
| K851984 | 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
