MBT — Dna-Probe, Reagent, Histoplasma Capsulatum Class II
FDA product code MBT covers "Dna-Probe, Reagent, Histoplasma Capsulatum", a Class II medical device regulated under 21 CFR 866.3320. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- MBT
- Device Class
- Class II
- Regulation Number
- 866.3320
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K896859 | gen-probe | ACCUPROBE HISTOPLASMA CAPSULATUM CULTURE CONF.TEST | February 1, 1990 |