Fluorometer, For Clinical Use

FDA product code KHO · 38 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.2560
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-09-27 – 2012-01-20

KHO 2012-01-20

AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..

Applicant Radiometer Medical Aps

K number K112161

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KHO 1998-01-13

TRIAGE STATMETER

Applicant Biosite Incorporated

K number K973547

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KHO 1997-06-27

AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Applicant Tosoh Medics, Inc.

K number K971103

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KHO 1996-10-18

VITROS IMMUNODIAGNOSTIC SYSTEM

Applicant Johnson & Johnson Clinical Diagnostics, Inc.

K number K962919

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KHO 1995-11-22

BIOCIRCUITS IOS (IN-OFFICE SYSTEM)

Applicant Biocircuits Corp.

K number K952719

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KHO 1995-09-05

FLUOROSCAN NEONATAL

Applicant Isolab, Inc.

K number K950415

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KHO 1994-05-23

AUTO DELFIA

Applicant Wallac OY

K number K935047

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KHO 1993-11-10

AUTOBEAD THYROID UPTAKE

Applicant Bio-Chem Laboratory Systems, Inc.

K number K930689

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KHO 1993-06-07

OPUS MAGNUM ANALYZER

Applicant Pb Diagnostic Systems, Inc.

K number K926131

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KHO 1992-07-21

AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Applicant Tosoh Corp.

K number K923021

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KHO 1992-03-19

MICROLITE MICROTITER PLATE LUMINOMETER ML2200

Applicant Dynatech Laboratories, Inc.

K number K920888

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KHO 1991-09-27

STRATUS IINTELLECT IMMUNOASSAY SYSTEM

Applicant Baxter Healthcare Corp

K number K913130

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KHO 1990-05-02

AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM

Applicant Tosoh Corp.

K number K901674

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KHO 1989-10-04

DELFIA PLATE FLUOROMETER 1232

Applicant Pharmacia, Inc.

K number K895240

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KHO 1989-08-03

OPUS IMMUNOASSAY SYSTEM

Applicant Pb Diagnostic Systems, Inc.

K number K894159

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KHO 1989-03-24

STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES

Applicant Baxter Healthcare Corp

K number K890908

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KHO 1987-09-02

CYBERFLUOR 615 IMMUNOANALYZER

Applicant Cyberfluor, Inc.

K number K872803

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KHO 1987-07-01

PFI-20 POLARIZING FLUORIMETER

Applicant The Perkin-Elmer Corp.

K number K871550

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KHO 1986-07-14

HEMAFLUOR REAGENT KIT

Applicant Helena Laboratories

K number K860309

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KHO 1985-05-24

LKB-WALLAC 1230 ARCUS FLUOROMETER

Applicant Lkb Instruments, Inc.

K number K851984

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KHO 1983-04-05

FLUOROMETER, GENERAL USE

Applicant Abbott Diagnostics

K number K830624

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KHO 1982-12-09

INNOTRON FLUORIMETER SERIES ONE-10

Applicant Innotron of Oregon, Inc.

K number K822942

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KHO 1982-11-29

CLINISTAT TDA SERIES

Applicant Miles Laboratories, Inc.

K number K823112

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KHO 1982-10-27

MICROFLUOR READER

Applicant Dynatech Corp.

K number K822772

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KHO 1982-10-08

FLUOROSTAT FLUOROMETER

Applicant Miles Laboratories, Inc.

K number K822701

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KHO 1981-12-31

A FLUOROMETER

Applicant American Diagnostic Corp.

K number K813540

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KHO 1981-11-27

SYVA ADVANCE TM FLUOROMETER

Applicant Syva Co.

K number K813146

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KHO 1981-04-29

LKB 4460 FLUORIMETER

Applicant Lkb Instruments, Inc.

K number K811019

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KHO 1980-11-12

CYBREX TM FPQ FLUORESCENE POLARIZATION

Applicant Abbott Laboratories

K number K802579

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KHO 1979-07-30

FLUOROMATIC ANALYZER AND AUTOSAMPLER

Applicant Bio-Rad

K number K791329

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KHO 1979-03-15

SPECTROPHOTOMETER MODEL 650-40

Applicant The Perkin-Elmer Corp.

K number K790236

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KHO 1979-03-15

SPECTROPHOTOMETER MODEL 3000

Applicant The Perkin-Elmer Corp.

K number K790235

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KHO 1978-03-27

SPECTROPHOTOMETER, FLUORESCENCE M.650-10

Applicant The Perkin-Elmer Corp.

K number K780242

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KHO 1978-03-22

SPECTROFLUOROMETER SF-330

Applicant Varian Assoc., Inc.

K number K780362

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KHO 1978-02-03

HTSH RIA

Applicant Abbott Laboratories

K number K780122

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KHO 1978-01-20

FLUORESCENCE DETECTOR MODEL 420

Applicant Waters Assoc., Inc.

K number K780031

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KHO 1976-10-28

HEMAFLOUR ZP

Applicant Buchler Instruments, Inc.

K number K760506

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KHO 1976-09-27

DETECTOR, MODEL LC-100 FLUORESCENCE

Applicant The Perkin-Elmer Corp.

K number K760261

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