510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852643Substantially Equivalent

Uni-Plate

Medical Specialties Laboratories, Boston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852643 is the FDA 510(k) clearance record for UNI-PLATE, cleared for Medical Specialties Laboratories on . FDA records list 5 510(k) clearances for Medical Specialties Laboratories, from to . As of , FDA records show no recalls naming K852643.

Clearance record

Decision date
Received
(48 days to decision)
Review panel
Unknown
Applicant
Medical Specialties Laboratories P.O.Box 659, Kenmore Station, Boston MA
Third party review
No