KHO · Class I · 21 CFR 862.2560

FDA Product Code KHO: Fluorometer, For Clinical Use

Leading manufacturers include The Perkin-Elmer Corp., Abbott Laboratories and Lkb Instruments, 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 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 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 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 Nov 29, 1982
CLINISTAT TDA SERIES
K823112
Miles Laboratories, Inc.
Toxicology · 39d
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
Cleared Nov 12, 1980
CYBREX TM FPQ FLUORESCENE POLARIZATION
K802579
Abbott Laboratories
Pathology · 23d
Cleared Jul 30, 1979
FLUOROMATIC ANALYZER AND AUTOSAMPLER
K791329
Bio-Rad
Chemistry · 12d
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 3000
K790235
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 15, 1979
SPECTROPHOTOMETER MODEL 650-40
K790236
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 27, 1978
SPECTROPHOTOMETER, FLUORESCENCE M.650-10
K780242
The Perkin-Elmer Corp.
Chemistry · 42d
Cleared Mar 22, 1978
SPECTROFLUOROMETER SF-330
K780362
Varian Assoc., Inc.
Toxicology · 16d

About Product Code KHO - Regulatory Context