510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
K852423Substantially Equivalent

Timentin 85Mcg Sensitivity Disc

Difco Laboratories, Inc., Detroit MI / Traditional, Substantially Equivalent

K852423 is the FDA 510(k) clearance record for TIMENTIN 85MCG SENSITIVITY DISC, cleared for Difco Laboratories, Inc. on . FDA records list 121 510(k) clearances for Difco Laboratories, Inc., from to . As of , FDA records show no recalls naming K852423.

Clearance record

Decision date
Received
(39 days to decision)
Review panel
Unknown
Applicant
Difco Laboratories, Inc. P. O. Box 331058, Detroit MI
Third party review
No