ROTATOR, FIXED SPEED
FDA 510(k) clearance K760467 · decided 1976-10-29
Clearance details
- K-number
- K760467
- Device name
- ROTATOR, FIXED SPEED
- Applicant
- Lederle Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1976-08-18
- Decision date
- 1976-10-29
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- JQC
- Device class
- 1
- Regulation number
- 862.2050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.