510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K852834Substantially Equivalent

Ortho Hematology Cont 14 Normal, 14 Abnormal H & L

Ortho Diagnostic Systems, Inc., Raritan NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852834 is the FDA 510(k) clearance record for ORTHO HEMATOLOGY CONT 14 NORMAL, 14 ABNORMAL H & L, cleared for Ortho Diagnostic Systems, Inc. on . FDA records list 126 510(k) clearances for Ortho Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K852834.

Clearance record

Decision date
Received
(37 days to decision)
Review panel
Unknown
Applicant
Ortho Diagnostic Systems, Inc. 1001 U.S. Hwy. 202, Raritan NJ
Third party review
No