Fungitell STAT
FDA 510(k) clearance K191167 · decided 2019-07-17
Clearance details
- K-number
- K191167
- Device name
- Fungitell STAT
- Applicant
- Associates of Cape Cod, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-05-01
- Decision date
- 2019-07-17
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- NQZ
- Device class
- 2
- Regulation number
- 866.3050
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- East Falmouth, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Associates of Cape Cod
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| GLUCATELL (DEN040003) | Associates of Cape Cod, Inc. | 2004-05-21 |
Recalls involving this device
No recalls on record reference this clearance.