| Device Type ID | 566 |
| Device Name | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Regulation Description | Densitometer/scanner (integrating, Reflectance, TLC, Or Radiochromatogram) For Clinical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2400 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JQT |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 566 |
| Device | Densitometer/scanner (integrating, Reflectance, Tlc, Radiochromat.) Clinica |
| Product Code | JQT |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Densitometer/scanner (integrating, Reflectance, TLC, Or Radiochromatogram) For Clinical Use. |
| CFR Regulation Number | 862.2400 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
SUBSTANTIALLY EQUIVALENT | 2 | |
ARLINGTON SCIENTIFIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Unintended Electrical Shock | 1 |
| Total Device Problems | 1 |