STA-QUALITY HBPM/LMWH KIT
FDA 510(k) clearance K010324 · decided 2001-04-09
Clearance details
- K-number
- K010324
- Device name
- STA-QUALITY HBPM/LMWH KIT
- Applicant
- Diagnostica Stago, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-02-02
- Decision date
- 2001-04-09
- Days to decision
- 66 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
No recalls on record reference this clearance.