GMK
- Product code
- GMK
- Device name
- Antiserum, Positive Control, Histoplasma Capsulatum
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3320
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 9
Official FDA classification page: GMK
Classification and pathway per current FDA publications. Data from openFDA (CC0).