Device Type ID | 5013 |
Device Name | Slide Stainer, Immersion Type |
Regulation Description | Automated Slide Stainer. |
Regulation Medical Specialty | Pathology |
Review Panel | Pathology |
Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 864.3800 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KIO |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 5013 |
Device | Slide Stainer, Immersion Type |
Product Code | KIO |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Automated Slide Stainer. |
CFR Regulation Number | 864.3800 [🔎] |