STA SYSTEM CONTROL [N] + [P] KIT
FDA 510(k) clearance K943518 · decided 1995-03-21
Clearance details
- K-number
- K943518
- Device name
- STA SYSTEM CONTROL [N] + [P] KIT
- Applicant
- American Bioproducts Co.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-21
- Decision date
- 1995-03-21
- Days to decision
- 243 days
- Clearance type
- Traditional
- Product code
- GGN
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Parisppany, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| STA SYSTEM CONROL N + P (ref. 00678) recall (Z-0738-2020) | Diagnostica Stago, Inc. | 2019-12-23 |
| STA - System Control N + P Product Usage: The STA -System Control N+P kit provides a norma recall (Z-1044-2012) | Diagnostica Stago, Inc. | 2012-02-16 |