CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
FDA 510(k) clearance K872426 · decided 1987-07-23
Clearance details
- K-number
- K872426
- Device name
- CYTOTECH C1-INHIBITOR ENZYME IMMUNOASSAY
- Applicant
- Cytotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-22
- Decision date
- 1987-07-23
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- DBA
- Device class
- 2
- Regulation number
- 866.5250
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| MicroVue C1-Inhibitor Plus EIA for measuring the amount of functional C1-lnhibitor protein recall (Z-1308-2023) | Quidel Corporation | 2023-03-30 |