NICALERT
FDA 510(k) clearance K021688 · decided 2002-10-18
Clearance details
- K-number
- K021688
- Device name
- NICALERT
- Applicant
- Nymox Pharmaceutical Corporation
- Decision
- Substantially Equivalent
- Date received
- 2002-05-22
- Decision date
- 2002-10-18
- Days to decision
- 149 days
- Clearance type
- Traditional
- Product code
- MRS
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Maywood, NJ, 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 |
|---|---|---|
| DRI COTININE EIA ASSAY (K030649) | Microgenics Corp. | 2003-05-22 |
| NICCHECK I (K963733) | Dynagen, Inc. | 1996-12-13 |
Recalls involving this device
No recalls on record reference this clearance.