Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2300](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2300) → JJQ — Colorimeter, Photometer, Spectrophotometer For Clinical Use # JJQ · Colorimeter, Photometer, Spectrophotometer For Clinical Use _Clinical Chemistry · 21 CFR 862.2300 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ ## Overview - **Product Code:** JJQ - **Device Name:** Colorimeter, Photometer, Spectrophotometer For Clinical Use - **Regulation:** [21 CFR 862.2300](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2300) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## 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](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K013371.md) | UBIT-IR300 INFRARED SPECTROMETRY SYSTEM | Otsuka Pharmaceutical Co., Ltd. | Dec 21, 2001 | SESE | | [K980120](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K980120.md) | DIGENE DML 2000 MICROPLATE LUMINOMETER | Digene Corp. | Feb 6, 1998 | SESE | | [K973938](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K973938.md) | ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER | Sfri, Inc. | Feb 4, 1998 | SESE | | [K974762](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K974762.md) | STAT TRACKS | Awareness Technology, Inc. | Jan 28, 1998 | SESE | | [K962113](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K962113.md) | ANTHOS PHACTS VERSION MICROPLATE READER | Columbia Bioscience, Inc. | Nov 5, 1996 | SESE | | [K961183](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K961183.md) | CBI 7520 READER | Columbia Bioscience, Inc. | Aug 2, 1996 | SESE | | [K962166](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K962166.md) | ORIGEN ANALYZER | Igen, Inc. | Jul 31, 1996 | SESE | | [K955077](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K955077.md) | ANTHOS 2010 READER | Anthos Labtec, Inc. | Dec 4, 1995 | SESE | | [K953710](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K953710.md) | ELX808 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | Oct 25, 1995 | SESE | | [K953572](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K953572.md) | ELX800UV | Bio-Tek Instruments, Inc. | Oct 19, 1995 | SESE | | [K953005](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K953005.md) | BILI-METER | Olympic Medical Corp. | Sep 28, 1995 | SESE | | [K950029](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K950029.md) | 5STRATEC SL 300 LIA-MAT | Nichols Institute Diagnostics | Aug 2, 1995 | SESE | | [K940486](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K940486.md) | DIGENE DCR-1 LUMINOMETER | Digene Diagnostics, Inc. | Apr 18, 1995 | SESE | | [K942361](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K942361.md) | WHITSOFT | Biowhittaker Molecular Applications, Inc. | Apr 4, 1995 | SESE | | [K942250](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K942250.md) | BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READER | Biowhittaker Molecular Applications, Inc. | Apr 4, 1995 | SESE | | [K942245](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K942245.md) | BIOWHITTAKER 2001 MICROPLATE READER FIRMWARE | Biowhittaker Molecular Applications, Inc. | Apr 3, 1995 | SESE | | [K950104](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K950104.md) | ELX800 AND EL800 AUTOMATED MICROPLATE READERS | Bio-Tek Instruments, Inc. | Mar 21, 1995 | SESE | | [K942923](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K942923.md) | CERES 900C & CERES UV900C | Bio-Tek Instruments, Inc. | Feb 6, 1995 | SESE | | [K943454](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K943454.md) | PLATO 3300/1300 | Rosys, Inc. | Jan 9, 1995 | SESE | | [K935983](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ/K935983.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JJQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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