N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
FDA 510(k) clearance K965100 · decided 1997-07-14
Clearance details
- K-number
- K965100
- Device name
- N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT
- Applicant
- Crestat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-20
- Decision date
- 1997-07-14
- Days to decision
- 206 days
- Clearance type
- Traditional
- Product code
- DEM
- Device class
- 2
- Regulation number
- 866.5130
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Weston, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| M/DN HUMERAL I/M NAIL. Sizes from 6 MM to 13 MM. Codes starting with 0022541, 002542 and 0 recall (Z-1011-2014) | Zimmer, Inc. | 2014-02-20 |