510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801018Substantially Equivalent

Immulon 1, #11-010-3350 & Immulon 2 #--

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

K801018 is the FDA 510(k) clearance record for IMMULON 1, #11-010-3350 & IMMULON 2 #--, cleared for Dynatech Laboratories, Inc. on . FDA records list 44 510(k) clearances for Dynatech Laboratories, Inc., from to . As of , FDA records show no recalls naming K801018.

Clearance record

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