Product code JQT
- Device name
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.2400
- 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 |
|---|---|---|---|
| K111356 | ASIMANAGER - AT | Arlington Scientific, Inc. | 2011-11-09 |
| K944185 | ISOSCAN | Isolab, Inc. | 1994-11-17 |
| K915332 | MODEL 795 FLUOROMETER/DENSITOMETER | Ciba Corning Diagnostics Corp. | 1992-02-18 |
| K885254 | TARGET READER | V-Tech, Inc. | 1989-01-27 |
| K860645 | ELECTROPHORESIS DATA CENTER (EDC) | Helena Laboratories | 1986-12-17 |
| K862956 | ICON READER | Hybritech, Inc. | 1986-08-19 |
| K853734 | APOLLO DENSITOMETER | Astral Medical Systems | 1985-09-25 |
| K851154 | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 | Astral Medical Systems | 1985-05-13 |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | 1985-03-12 |
| K850260 | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | Gelman Sciences, Inc. | 1985-02-27 |
| K842313 | ELVI 146 SEROSCAN | Logos Scientific, Inc. | 1984-09-10 |
| K842056 | ELVI 165 PROTEO SEROSKOP | Logos Scientific, Inc. | 1984-06-22 |
| K810619 | 710 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | 1981-03-27 |
| K803240 | CORNING 760 FLUOROMETER/DENSITOMETER | Transidyne General Corp. | 1981-01-09 |
| K780901 | AUTOMATED ELECTROPHORESIS SYSTEM | Olympus Corp. | 1978-06-28 |
| K780318 | MODULAR SCANNING DENSITOMETER SYS. | Transidyne General Corp. | 1978-04-12 |
| K772325 | DENSITOMETER 18, COMPUTING, AUTO. | Gelman Instrument Co. | 1978-01-12 |
| K770026 | FLOUROMETER/DENSITOMETER MODEL 720 | Corning Medical & Scientific | 1977-01-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07070060008042 | Alere Afinion™ AS100 | Abbott Diagnostics Technologies AS | 2023-10-26 |
| 07070060014616 | Afinion™ 2 | Abbott Diagnostics Technologies AS | 2023-10-26 |
| 07070060014623 | Afinion™ 2 | Abbott Diagnostics Technologies AS | 2023-10-26 |
| 07070060014692 | Afinion™ 2 | Abbott Diagnostics Technologies AS | 2023-10-26 |
| 07070060014708 | Afinion™ 2 | Abbott Diagnostics Technologies AS | 2023-10-26 |
| EVIRUVCCAM1 | ViraChip Reader | Viramed Biotech AG | 2023-07-17 |
| EVIRUVCSCA1 | ViraChip Scanner | Viramed Biotech AG | 2023-07-17 |
| 04049016068785 | EUROLineScan | EUROIMMUN Medizinische Labordiagnostika AG | 2022-12-08 |
| 00895160002014 | Nano-CheckerTM 710 Reader | NANO-DITECH CORPORATION | 2019-03-29 |
| 00867802000290 | xReader System | ESCREEN, INC. | 2016-09-16 |
| 00816057020041 | ASiManager-AT | ARLINGTON SCIENTIFIC, INC. | 2016-07-08 |