JQTClass I
Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
21 CFR 862.2400 / Clinical Chemistry
JQT is the FDA product code for Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica, a class I device type, regulated under 21 CFR 862.2400. As of , FDA records hold 18 510(k) clearances under this code, the most recent dated , and no recalls.
Classification record
- Product code
- JQT
- Device name
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- Regulation
- 21 CFR 862.2400
- Device class
- Class I
- Review panel
- Clinical Chemistry
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 18
- Ingested recalls
- 0
Clearances, product code JQT
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 3 |
| 1981 | 2 |
| 1984 | 2 |
| 1985 | 4 |
| 1986 | 2 |
| 1989 | 1 |
| 1992 | 1 |
| 1994 | 1 |
| 2011 | 1 |
Applicants with the most clearances
Product code JQT| Applicant | Clearances |
|---|---|
| Corning Medical & Scientific | 3 |
| Astral Medical Systems | 2 |
| Logos Scientific, Inc. | 2 |
| Transidyne General Corp. | 2 |
| Arlington Scientific, Inc. | 1 |
| Ciba Corning Diagnostics Corp. | 1 |
| Gelman Instrument Co. | 1 |
| Gelman Sciences, Inc. | 1 |
| Helena Laboratories, Corp. | 1 |
| Hybritech, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
