510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812416Substantially Equivalent

Mark 500 System

Kallestad Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812416 is the FDA 510(k) clearance record for MARK 500 SYSTEM, cleared for Kallestad Laboratories, Inc. on . FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from to . As of , FDA records show no recalls naming K812416.

Clearance record

Decision date
Received
(227 days to decision)
Review panel
Unknown
Applicant
Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No