JSY
- Product code
- JSY
- Device name
- Kit, Identification, Mycobacteria
- Device class
- Class 1
- 21 CFR
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 5 (all years; only the last 3 years are listed here)
Official FDA classification page: JSY
Classification and pathway per current FDA publications. Data from openFDA (CC0).