STATUSFLOW
FDA 510(k) clearance K982231 · decided 1998-07-20
Clearance details
- K-number
- K982231
- Device name
- STATUSFLOW
- Applicant
- R&D Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-06-25
- Decision date
- 1998-07-20
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BD Multi Check CD4 Low Control Catalog No. 340916 is intended as a complete process contro recall (Z-2233-2014) | BD Biosciences, Systems & Reagents | 2014-08-14 |