Device Type ID | 4778 |
Device Name | Stain, Trichrome, Mallory's |
Regulation Description | Dye And Chemical Solution Stains. |
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 | 864.1850 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HYW |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4778 |
Device | Stain, Trichrome, Mallory's |
Product Code | HYW |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Dye And Chemical Solution Stains. |
CFR Regulation Number | 864.1850 [🔎] |