Fungitell STAT— 510(k) K191167
Substantially EquivalentAssociates of Cape Cod, Inc.
FDA 510(k) clearance K191167 for Fungitell STAT, Substantially Equivalent on 2019-07-17. Applicant: Associates of Cape Cod, Inc.. Device class: 2.
Clearance details
- Applicant
- Associates of Cape Cod, Inc.
- Product code
- Code NQZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3050
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- East Falmouth, MA, US
Recent devices under product code NQZ
view allRecalls naming K191167
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191167.
Data sourced from openFDA. This site is unofficial and independent of the FDA.