JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use
Clinical Chemistry · 21 CFR 862.2300 · Class 1
Overview
| Product Code | JJQ |
|---|---|
| Device Name | Colorimeter, Photometer, Spectrophotometer For Clinical Use |
| Regulation | 21 CFR 862.2300 |
| Device Class | Class 1 |
| Review Panel | Clinical Chemistry |
Identification
A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
Recent Cleared Devices (20 of 258)
Showing 20 most recent of 258 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K013371 | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | Otsuka Pharmaceutical Co., Ltd. | Dec 21, 2001 | SESE |
| K980120 | DIGENE DML 2000 MICROPLATE LUMINOMETER | Digene Corp. | Feb 6, 1998 | SESE |
| K973938 | ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER | Sfri, Inc. | Feb 4, 1998 | SESE |
| K974762 | STAT TRACKS | Awareness Technology, Inc. | Jan 28, 1998 | SESE |
| K962113 | ANTHOS PHACTS VERSION MICROPLATE READER | Columbia Bioscience, Inc. | Nov 5, 1996 | SESE |
| K961183 | CBI 7520 READER | Columbia Bioscience, Inc. | Aug 2, 1996 | SESE |
| K962166 | ORIGEN ANALYZER | Igen, Inc. | Jul 31, 1996 | SESE |
| K955077 | ANTHOS 2010 READER | Anthos Labtec, Inc. | Dec 4, 1995 | SESE |
| K953710 | ELX808 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | Oct 25, 1995 | SESE |
| K953572 | ELX800UV | Bio-Tek Instruments, Inc. | Oct 19, 1995 | SESE |
| K953005 | BILI-METER | Olympic Medical Corp. | Sep 28, 1995 | SESE |
| K950029 | 5STRATEC SL 300 LIA-MAT | Nichols Institute Diagnostics | Aug 2, 1995 | SESE |
| K940486 | DIGENE DCR-1 LUMINOMETER | Digene Diagnostics, Inc. | Apr 18, 1995 | SESE |
| K942361 | WHITSOFT | Biowhittaker Molecular Applications, Inc. | Apr 4, 1995 | SESE |
| K942250 | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | Biowhittaker Molecular Applications, Inc. | Apr 4, 1995 | SESE |
| K942245 | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | Biowhittaker Molecular Applications, Inc. | Apr 3, 1995 | SESE |
| K950104 | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | Mar 21, 1995 | SESE |
| K942923 | CERES 900C & CERES UV900C | Bio-Tek Instruments, Inc. | Feb 6, 1995 | SESE |
| K943454 | PLATO 3300/1300 | Rosys, Inc. | Jan 9, 1995 | SESE |
| K935983 | MICROREADER 4 | Hyperion, Inc. | Dec 9, 1994 | SESE |
Top Applicants
- Dynatech Laboratories, Inc. — 15 clearances
- Bio-Tek Instruments, Inc. — 14 clearances
- Awareness Technology, Inc. — 8 clearances
- Lkb Instruments, Inc. — 7 clearances
- Varian Assoc., Inc. — 7 clearances
