KHO · Class I · 21 CFR 862.2560

FDA Product Code KHO: Fluorometer, For Clinical Use

Leading manufacturers include The Perkin-Elmer Corp., Lkb Instruments, Inc. and Miles Laboratories, Inc..

38
Total
38
Cleared
71d
Avg days
1976
Since

FDA 510(k) Cleared Fluorometer, For Clinical Use Devices (Product Code KHO)

38 devices
1–24 of 38
Cleared Jan 20, 2012
AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..
K112161
Radiometer Medical Aps
Chemistry · 177d
Cleared Jan 13, 1998
TRIAGE STATMETER
K973547
Biosite Incorporated
Chemistry · 117d
Cleared Jun 27, 1997
AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM
K971103
Tosoh Medics, Inc.
Chemistry · 93d
Cleared Oct 18, 1996
VITROS IMMUNODIAGNOSTIC SYSTEM
K962919
Johnson & Johnson Clinical Diagnostics, Inc.
Chemistry · 84d
Cleared Sep 05, 1995
FLUOROSCAN NEONATAL
K950415
Isolab, Inc.
Chemistry · 217d
Cleared May 23, 1994
AUTO DELFIA
K935047
Wallac OY
Chemistry · 214d
Cleared Jun 07, 1993
OPUS MAGNUM ANALYZER
K926131
Pb Diagnostic Systems, Inc.
Chemistry · 182d
Cleared Mar 19, 1992
MICROLITE MICROTITER PLATE LUMINOMETER ML2200
K920888
Dynatech Laboratories, Inc.
Chemistry · 37d
Cleared Sep 27, 1991
STRATUS IINTELLECT IMMUNOASSAY SYSTEM
K913130
Baxter Healthcare Corp
Chemistry · 73d
Cleared Oct 04, 1989
DELFIA PLATE FLUOROMETER 1232
K895240
Pharmacia, Inc.
Chemistry · 44d
Cleared Aug 03, 1989
OPUS IMMUNOASSAY SYSTEM
K894159
Pb Diagnostic Systems, Inc.
Toxicology · 50d
Cleared Mar 24, 1989
STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES
K890908
Baxter Healthcare Corp
Chemistry · 29d
Cleared Sep 02, 1987
CYBERFLUOR 615 IMMUNOANALYZER
K872803
Cyberfluor, Inc.
Chemistry · 49d
Cleared Jul 01, 1987
PFI-20 POLARIZING FLUORIMETER
K871550
The Perkin-Elmer Corp.
Chemistry · 70d
Cleared Jul 14, 1986
HEMAFLUOR REAGENT KIT
K860309
Helena Laboratories
Chemistry · 167d
Cleared May 24, 1985
LKB-WALLAC 1230 ARCUS FLUOROMETER
K851984
Lkb Instruments, Inc.
Chemistry · 17d
Cleared Apr 05, 1983
FLUOROMETER, GENERAL USE
K830624
Abbott Diagnostics
Toxicology · 36d
Cleared Dec 09, 1982
INNOTRON FLUORIMETER SERIES ONE-10
K822942
Innotron of Oregon, Inc.
Chemistry · 66d
Cleared Nov 29, 1982
CLINISTAT TDA SERIES
K823112
Miles Laboratories, Inc.
Toxicology · 39d
Cleared Oct 27, 1982
MICROFLUOR READER
K822772
Dynatech Corp.
Chemistry · 43d
Cleared Oct 08, 1982
FLUOROSTAT FLUOROMETER
K822701
Miles Laboratories, Inc.
Chemistry · 31d
Cleared Dec 31, 1981
A FLUOROMETER
K813540
American Diagnostic Corp.
Chemistry · 10d
Cleared Nov 27, 1981
SYVA ADVANCE TM FLUOROMETER
K813146
Syva Co.
Chemistry · 21d
Cleared Apr 29, 1981
LKB 4460 FLUORIMETER
K811019
Lkb Instruments, Inc.
Chemistry · 14d

About Product Code KHO - Regulatory Context