QCA (VERSION 3.1)
FDA 510(k) clearance K031363 · decided 2004-02-05
Clearance details
- K-number
- K031363
- Device name
- QCA (VERSION 3.1)
- Applicant
- Cell Analysis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-30
- Decision date
- 2004-02-05
- Days to decision
- 281 days
- Clearance type
- Abbreviated
- Product code
- NQN
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Evanston, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| QCA and iQCA software, a video microscopy software system for quantitative estrogen recept recall (Z-1040-2009) | Leica Microsystems, Inc. | 2009-03-24 |