GLUCATELL
FDA 510(k) clearance DEN040003 · decided 2004-05-21
Clearance details
- K-number
- DEN040003
- Device name
- GLUCATELL
- Applicant
- Associates of Cape Cod, Inc.
- Decision
- Unknown
- Date received
- 2004-03-22
- Decision date
- 2004-05-21
- Days to decision
- 60 days
- Clearance type
- Post-NSE
- Product code
- NQZ
- Device class
- 2
- Regulation number
- 866.3050
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Woodbury, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fungitell STAT (K191167) | Associates of Cape Cod, Inc. | 2019-07-17 |
Recalls involving this device
No recalls on record reference this clearance.