NICCHECK I
FDA 510(k) clearance K963733 · decided 1996-12-13
Clearance details
- K-number
- K963733
- Device name
- NICCHECK I
- Applicant
- Dynagen, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-09-16
- Decision date
- 1996-12-13
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- MRS
- Device class
- 1
- Regulation number
- 862.3220
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Cambridge, MA, 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 |
| NICALERT (K021688) | Nymox Pharmaceutical Corporation | 2002-10-18 |
Recalls involving this device
No recalls on record reference this clearance.