Device Type ID | 4838 |
Device Name | Kit, Culture, Chromosome |
Regulation Description | Chromosome Culture Kit. |
Regulation Medical Specialty | Hematology |
Review Panel | Pathology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.2260 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KIQ |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4838 |
Device | Kit, Culture, Chromosome |
Product Code | KIQ |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Chromosome Culture Kit. |
CFR Regulation Number | 864.2260 [🔎] |