UNI-PLATE
FDA 510(k) clearance K852643 · decided 1985-08-08
Clearance details
- K-number
- K852643
- Device name
- UNI-PLATE
- Applicant
- Medical Specialties Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1985-06-21
- Decision date
- 1985-08-08
- Days to decision
- 48 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Boston, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.