Browse hierarchy: [Clinical Chemistry (CH)](/submissions/CH) → [Subpart C — Clinical Laboratory Instruments](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments) → [21 CFR 862.2400](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2400) → JQT — Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica # JQT · Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica _Clinical Chemistry · 21 CFR 862.2400 · Class 1_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT ## Overview - **Product Code:** JQT - **Device Name:** Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica - **Regulation:** [21 CFR 862.2400](/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/862.2400) - **Device Class:** 1 - **Review Panel:** [Clinical Chemistry](/submissions/CH) ## Identification A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram. ## 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 (18 of 18) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K111356](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K111356.md) | ASIMANAGER - AT | Arlington Scientific, Inc. | Nov 9, 2011 | SESE | | [K944185](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K944185.md) | ISOSCAN | Isolab, Inc. | Nov 17, 1994 | SESE | | [K915332](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K915332.md) | MODEL 795 FLUOROMETER/DENSITOMETER | Ciba Corning Diagnostics Corp. | Feb 18, 1992 | SESE | | [K885254](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K885254.md) | TARGET READER | V-Tech, Inc. | Jan 27, 1989 | SESE | | [K860645](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K860645.md) | ELECTROPHORESIS DATA CENTER (EDC) | Helena Laboratories | Dec 17, 1986 | SESE | | [K862956](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K862956.md) | ICON READER | Hybritech, Inc. | Aug 19, 1986 | SESE | | [K853734](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K853734.md) | APOLLO DENSITOMETER | Astral Medical Systems | Sep 25, 1985 | SESE | | [K851154](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K851154.md) | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 | Astral Medical Systems | May 13, 1985 | SESE | | [K850617](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K850617.md) | CORNING 780 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | Mar 12, 1985 | SESE | | [K850260](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K850260.md) | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | Gelman Sciences, Inc. | Feb 27, 1985 | SESE | | [K842313](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K842313.md) | ELVI 146 SEROSCAN | Logos Scientific, Inc. | Sep 10, 1984 | SESE | | [K842056](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K842056.md) | ELVI 165 PROTEO SEROSKOP | Logos Scientific, Inc. | Jun 22, 1984 | SESE | | [K810619](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K810619.md) | 710 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | Mar 27, 1981 | SESE | | [K803240](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K803240.md) | CORNING 760 FLUOROMETER/DENSITOMETER | Transidyne General Corp. | Jan 9, 1981 | SESE | | [K780901](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K780901.md) | AUTOMATED ELECTROPHORESIS SYSTEM | Olympus Corp. | Jun 28, 1978 | SESE | | [K780318](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K780318.md) | MODULAR SCANNING DENSITOMETER SYS. | Transidyne General Corp. | Apr 12, 1978 | SESE | | [K772325](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K772325.md) | DENSITOMETER 18, COMPUTING, AUTO. | Gelman Instrument Co. | Jan 12, 1978 | SESE | | [K770026](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT/K770026.md) | FLOUROMETER/DENSITOMETER MODEL 720 | Corning Medical & Scientific | Jan 26, 1977 | SESE | ## Top Applicants - Corning Medical & Scientific — 3 clearances - Astral Medical Systems — 2 clearances - Logos Scientific, Inc. — 2 clearances - Transidyne General Corp. — 2 clearances - Arlington Scientific, Inc. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT](https://fda.innolitics.com/submissions/CH/subpart-c%E2%80%94clinical-laboratory-instruments/JQT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com