510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830785Substantially Equivalent

Leeco Dig-Quant Diag. Test Kit

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

K830785 is the FDA 510(k) clearance record for LEECO DIG-QUANT DIAG. TEST KIT, cleared for Leeco Diagnostics, Inc. on . FDA records list 49 510(k) clearances for Leeco Diagnostics, Inc., from to . As of , FDA records show no recalls naming K830785.

Clearance record

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