CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
FDA 510(k) clearance K000897 · decided 2000-05-05
Clearance details
- K-number
- K000897
- Device name
- CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
- Applicant
- Bd Biosciences
- Decision
- Substantially Equivalent
- Date received
- 2000-03-21
- Decision date
- 2000-05-05
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- GKZ
- Device class
- 2
- Regulation number
- 864.5220
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.