GBACT + KIT
FDA 510(k) clearance K984141 · decided 1999-05-28
Clearance details
- K-number
- K984141
- Device name
- GBACT + KIT
- Applicant
- Sienco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-18
- Decision date
- 1999-05-28
- Days to decision
- 191 days
- Clearance type
- Special
- Product code
- JBP
- Device class
- 2
- Regulation number
- 864.7140
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Wheatridge, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.