510(k) K852643
K852643 is an FDA 510(k) premarket notification submitted by Medical Specialties Laboratories for the device "UNI-PLATE". The FDA issued a decision of Substantially Equivalent on August 8, 1985. Medical Specialties Laboratories has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1985
- Date Received
- June 21, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No