UNIVERSAL CENTRIFUGE
FDA 510(k) clearance K822716 · decided 1982-09-30
Clearance details
- K-number
- K822716
- Device name
- UNIVERSAL CENTRIFUGE
- Applicant
- Biodynamics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-07
- Decision date
- 1982-09-30
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- JPI
- Device class
- 2
- Regulation number
- 864.6400
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.