Product code JJQ
- Device name
- Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2300
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | Otsuka Pharmaceutical Co., Ltd. | 2001-12-21 |
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER | Digene Corp. | 1998-02-06 |
| K973938 | ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER | Sfri, Inc. | 1998-02-04 |
| K974762 | STAT TRACKS | Awareness Technology, Inc. | 1998-01-28 |
| K962113 | ANTHOS PHACTS VERSION MICROPLATE READER | Columbia Bioscience, Inc. | 1996-11-05 |
| K961183 | CBI 7520 READER | Columbia Bioscience, Inc. | 1996-08-02 |
| K962166 | ORIGEN ANALYZER | Igen, Inc. | 1996-07-31 |
| K955077 | ANTHOS 2010 READER | Anthos Labtec, Inc. | 1995-12-04 |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | 1995-10-25 |
| K953572 | ELX800UV | Bio-Tek Instruments, Inc. | 1995-10-19 |
| K953005 | BILI-METER | Olympic Medical Corp. | 1995-09-28 |
| K950029 | 5STRATEC SL 300 LIA-MAT | Nichols Institute Diagnostics | 1995-08-02 |
| K940486 | DIGENE DCR-1 LUMINOMETER | Digene Diagnostics, Inc. | 1995-04-18 |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | Biowhittaker Molecular Applications, Inc. | 1995-04-04 |
| K942361 | WHITSOFT | Biowhittaker Molecular Applications, Inc. | 1995-04-04 |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | Biowhittaker Molecular Applications, Inc. | 1995-04-03 |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | 1995-03-21 |
| K942923 | CERES 900C & CERES UV900C | Bio-Tek Instruments, Inc. | 1995-02-06 |
| K943454 | PLATO 3300/1300 | Rosys, Inc. | 1995-01-09 |
| K935983 | MICROREADER 4 | Hyperion, Inc. | 1994-12-09 |
| K943595 | SERUM/URINE APPLI ILAB(TM) CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | 1994-11-28 |
| K941050 | DUPONT ACA STAR | Dupont Medical Products | 1994-11-10 |
| K943701 | MRX MICROPLATE READER | Dynatech Laboratories, Inc. | 1994-10-20 |
| K932778 | BOEHRINGER MANNHEIM ES 300 AL(AUTOLOADER) ANALYZER | Boehringer Mannheim Corp. | 1993-11-17 |
| K932467 | ILAB 900/1800 CLINICAL CHEMISTRY SYSTEM | Instrumentation Laboratory CO | 1993-11-05 |
| K921536 | ACCULYTE CHEMILUMINESCENCE ANALYZER | Laboratory Technologies, Inc. | 1993-10-12 |
| K931907 | ANTHOS HT READERS, INCLUDING THE ANTHOS HT II&III | Anthos Labtec Instruments | 1993-09-29 |
| K925625 | OMNI | Bio-Tek Instruments, Inc. | 1993-08-19 |
| K925935 | OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER | Olympus Corp. | 1993-04-22 |
| K923844 | LYRIS 100/120 LABORATORY INFORMATION SYSTEM | Biovation, Inc. | 1992-12-11 |
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| 07290016923223 | BreathID Smart System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2021-12-15 |
| 07290016923070 | BreathID Hp Lab System | MERIDIAN BIOSCIENCE ISRAEL LTD | 2021-12-15 |
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| 10743816001362 | Dxpress Reader | PRINCETON BIOMEDITECH CORPORATION | 2016-09-23 |
| 10837461002529 | iChem | IRIS INTERNATIONAL, INC. | 2016-09-07 |