STATSPIN MINI-PLASMA
FDA 510(k) clearance K893613 · decided 1989-08-28
Clearance details
- K-number
- K893613
- Device name
- STATSPIN MINI-PLASMA
- Applicant
- Statspin Technologies
- Decision
- Substantially Equivalent
- Date received
- 1989-05-10
- Decision date
- 1989-08-28
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- JKA
- Device class
- 2
- Regulation number
- 862.1675
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Norwood, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.