Atlas FDA

KHO

38 FDA 510(k) clearances · Product code

43 daysmedian time to decision
182 days90th percentile
38clearances measured

FDA profile

Official device name
Fluorometer, For Clinical Use
Device class
Class I (low risk)
Regulation
21 CFR 862.2560
Medical specialty
Clinical Chemistry
Adverse events (MAUDE)
2021: 213 · 2022: 224 · 2023: 260 · 2024: 168 · 2025: 181 · 2026: 101
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. (K112161)Radiometer Medical Aps2012-01-20
TRIAGE STATMETER (K973547)Biosite Incorporated1998-01-13
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K971103)Tosoh Medics, Inc.1997-06-27
VITROS IMMUNODIAGNOSTIC SYSTEM (K962919)Johnson & Johnson Clinical Diagnostics, Inc.1996-10-18
BIOCIRCUITS IOS (IN-OFFICE SYSTEM) (K952719)Biocircuits Corp.1995-11-22
FLUOROSCAN NEONATAL (K950415)Isolab, Inc.1995-09-05
AUTO DELFIA (K935047)Wallac OY1994-05-23
AUTOBEAD THYROID UPTAKE (K930689)Bio-Chem Laboratory Systems, Inc.1993-11-10
OPUS MAGNUM ANALYZER (K926131)Pb Diagnostic Systems, Inc.1993-06-07
AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K923021)Tosoh Corp.1992-07-21
MICROLITE MICROTITER PLATE LUMINOMETER ML2200 (K920888)Dynatech Laboratories, Inc.1992-03-19
STRATUS IINTELLECT IMMUNOASSAY SYSTEM (K913130)Baxter Healthcare Corp1991-09-27
AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM (K901674)Tosoh Corp.1990-05-02
DELFIA PLATE FLUOROMETER 1232 (K895240)Pharmacia, Inc.1989-10-04
OPUS IMMUNOASSAY SYSTEM (K894159)Pb Diagnostic Systems, Inc.1989-08-03
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES (K890908)Baxter Healthcare Corp1989-03-24
CYBERFLUOR 615 IMMUNOANALYZER (K872803)Cyberfluor, Inc.1987-09-02
PFI-20 POLARIZING FLUORIMETER (K871550)The Perkin-Elmer Corp.1987-07-01
HEMAFLUOR REAGENT KIT (K860309)Helena Laboratories1986-07-14
LKB-WALLAC 1230 ARCUS FLUOROMETER (K851984)Lkb Instruments, Inc.1985-05-24
FLUOROMETER, GENERAL USE (K830624)Abbott Diagnostics1983-04-05
INNOTRON FLUORIMETER SERIES ONE-10 (K822942)Innotron of Oregon, Inc.1982-12-09
CLINISTAT TDA SERIES (K823112)Miles Laboratories, Inc.1982-11-29
MICROFLUOR READER (K822772)Dynatech Corp.1982-10-27
FLUOROSTAT FLUOROMETER (K822701)Miles Laboratories, Inc.1982-10-08
A FLUOROMETER (K813540)American Diagnostic Corp.1981-12-31
SYVA ADVANCE TM FLUOROMETER (K813146)Syva Co.1981-11-27
LKB 4460 FLUORIMETER (K811019)Lkb Instruments, Inc.1981-04-29
CYBREX TM FPQ FLUORESCENE POLARIZATION (K802579)Abbott Laboratories1980-11-12
FLUOROMATIC ANALYZER AND AUTOSAMPLER (K791329)Bio-Rad1979-07-30
SPECTROPHOTOMETER MODEL 3000 (K790235)The Perkin-Elmer Corp.1979-03-15
SPECTROPHOTOMETER MODEL 650-40 (K790236)The Perkin-Elmer Corp.1979-03-15
SPECTROPHOTOMETER, FLUORESCENCE M.650-10 (K780242)The Perkin-Elmer Corp.1978-03-27
SPECTROFLUOROMETER SF-330 (K780362)Varian Assoc., Inc.1978-03-22
HTSH RIA (K780122)Abbott Laboratories1978-02-03
FLUORESCENCE DETECTOR MODEL 420 (K780031)Waters Assoc., Inc.1978-01-20
HEMAFLOUR ZP (K760506)Buchler Instruments, Inc.1976-10-28
DETECTOR, MODEL LC-100 FLUORESCENCE (K760261)The Perkin-Elmer Corp.1976-09-27

Track KHO automatically

Every clearance here is in the API, with alerts when new ones post.