| Device Type ID | 5972 | 
| Device Name | Tanks, Developing, Tlc | 
| Regulation Description | Thin-layer Chromatography System For Clinical Use. | 
| Regulation Medical Specialty | Clinical Chemistry | 
| Review Panel | Toxicology | 
| Premarket Review |   Office Of In Vitro Diagnostics And Radiological Health  (OIR)   | 
| Submission Type | 510(K) Exempt | 
| CFR Regulation Number | 862.2270 [🔎] | 
| FDA Device Classification | Class 1 Medical Device | 
| Product Code | DKK | 
| GMP Exempt | Yes | 
| Summary MR | Eligible | 
| Implanted Device | No | 
| Life Support Device | No | 
| Third Party Review |  Not Third Party Eligible   |