510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K863920Substantially Equivalent

Wako(tm) Zn Test

FUJIFILM Healthcare Americas Corporation, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863920 is the FDA 510(k) clearance record for WAKO(TM) ZN TEST, cleared for Wako Chemicals USA, Inc. on . FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K863920.

Clearance record

Decision date
Received
(343 days to decision)
Review panel
Unknown
Applicant
Wako Chemicals USA, Inc. 12300 Ford Rd., Dallas TX
Third party review
No