FDA Product Code
FDA Product Code KHO — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.2560
510(k) Clearances — 38 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| 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 | 2012-01-20 | Traditional | PDF ↗ |
| K973547 | TRIAGE STATMETER | Biosite Incorporated | 1998-01-13 | Traditional | PDF ↗ |
| K971103 | AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Medics, Inc. | 1997-06-27 | Traditional | PDF ↗ |
| K962919 | VITROS IMMUNODIAGNOSTIC SYSTEM | Johnson & Johnson Clinical Diagnostics, Inc. | 1996-10-18 | Traditional | PDF ↗ |
| K952719 | BIOCIRCUITS IOS (IN-OFFICE SYSTEM) | Biocircuits Corp. | 1995-11-22 | Traditional | PDF ↗ |
| K950415 | FLUOROSCAN NEONATAL | Isolab, Inc. | 1995-09-05 | Traditional | PDF ↗ |
| K935047 | AUTO DELFIA | Wallac OY | 1994-05-23 | Traditional | PDF ↗ |
| K930689 | AUTOBEAD THYROID UPTAKE | Bio-Chem Laboratory Systems, Inc. | 1993-11-10 | Traditional | PDF ↗ |
| K926131 | OPUS MAGNUM ANALYZER | Pb Diagnostic Systems, Inc. | 1993-06-07 | Traditional | PDF ↗ |
| K923021 | AIA-1200DX - AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | 1992-07-21 | Traditional | PDF ↗ |
| K920888 | MICROLITE MICROTITER PLATE LUMINOMETER ML2200 | Dynatech Laboratories, Inc. | 1992-03-19 | Traditional | PDF ↗ |
| K913130 | STRATUS IINTELLECT IMMUNOASSAY SYSTEM | Baxter Healthcare Corp | 1991-09-27 | Traditional | PDF ↗ |
| K901674 | AIA-600 AUTOMATED ENZYME IMMUNOASSAY SYSTEM | Tosoh Corp. | 1990-05-02 | Traditional | PDF ↗ |
| K895240 | DELFIA PLATE FLUOROMETER 1232 | Pharmacia, Inc. | 1989-10-04 | Traditional | PDF ↗ |
| K894159 | OPUS IMMUNOASSAY SYSTEM | Pb Diagnostic Systems, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K890908 | STRATUS(R) II FLUOROMETRIC ANALYZER & ACCESSORIES | Baxter Healthcare Corp | 1989-03-24 | Traditional | PDF ↗ |
| K872803 | CYBERFLUOR 615 IMMUNOANALYZER | Cyberfluor, Inc. | 1987-09-02 | Traditional | PDF ↗ |
| K871550 | PFI-20 POLARIZING FLUORIMETER | The Perkin-Elmer Corp. | 1987-07-01 | Traditional | PDF ↗ |
| K860309 | HEMAFLUOR REAGENT KIT | Helena Laboratories | 1986-07-14 | Traditional | PDF ↗ |
| K851984 | LKB-WALLAC 1230 ARCUS FLUOROMETER | Lkb Instruments, Inc. | 1985-05-24 | Traditional | PDF ↗ |
| K830624 | FLUOROMETER, GENERAL USE | Abbott Diagnostics | 1983-04-05 | Traditional | PDF ↗ |
| K822942 | INNOTRON FLUORIMETER SERIES ONE-10 | Innotron of Oregon, Inc. | 1982-12-09 | Traditional | PDF ↗ |
| K823112 | CLINISTAT TDA SERIES | Miles Laboratories, Inc. | 1982-11-29 | Traditional | PDF ↗ |
| K822772 | MICROFLUOR READER | Dynatech Corp. | 1982-10-27 | Traditional | PDF ↗ |
| K822701 | FLUOROSTAT FLUOROMETER | Miles Laboratories, Inc. | 1982-10-08 | Traditional | PDF ↗ |
| K813540 | A FLUOROMETER | American Diagnostic Corp. | 1981-12-31 | Traditional | PDF ↗ |
| K813146 | SYVA ADVANCE TM FLUOROMETER | Syva Co. | 1981-11-27 | Traditional | PDF ↗ |
| K811019 | LKB 4460 FLUORIMETER | Lkb Instruments, Inc. | 1981-04-29 | Traditional | PDF ↗ |
| K802579 | CYBREX TM FPQ FLUORESCENE POLARIZATION | Abbott Laboratories | 1980-11-12 | Traditional | PDF ↗ |
| K791329 | FLUOROMATIC ANALYZER AND AUTOSAMPLER | Bio-Rad | 1979-07-30 | Traditional | PDF ↗ |
| K790235 | SPECTROPHOTOMETER MODEL 3000 | The Perkin-Elmer Corp. | 1979-03-15 | Traditional | PDF ↗ |
| K790236 | SPECTROPHOTOMETER MODEL 650-40 | The Perkin-Elmer Corp. | 1979-03-15 | Traditional | PDF ↗ |
| K780242 | SPECTROPHOTOMETER, FLUORESCENCE M.650-10 | The Perkin-Elmer Corp. | 1978-03-27 | Traditional | PDF ↗ |
| K780362 | SPECTROFLUOROMETER SF-330 | Varian Assoc., Inc. | 1978-03-22 | Traditional | PDF ↗ |
| K780122 | HTSH RIA | Abbott Laboratories | 1978-02-03 | Traditional | PDF ↗ |
| K780031 | FLUORESCENCE DETECTOR MODEL 420 | Waters Assoc., Inc. | 1978-01-20 | Traditional | PDF ↗ |
| K760506 | HEMAFLOUR ZP | Buchler Instruments, Inc. | 1976-10-28 | Traditional | PDF ↗ |
| K760261 | DETECTOR, MODEL LC-100 FLUORESCENCE | The Perkin-Elmer Corp. | 1976-09-27 | Traditional | PDF ↗ |
Product code KHO · Class I · Clinical Chemistry. Data: openFDA.