510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K840801Substantially Equivalent

Dia-H 1/2/3 & Dia-Ht 1/2/3

Diatech, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840801 is the FDA 510(k) clearance record for DIA-H 1/2/3 & DIA-HT 1/2/3, cleared for Diatech, Inc. on . FDA records list 17 510(k) clearances for Diatech, Inc., from to . As of , FDA records show no recalls naming K840801.

Clearance record

Decision date
Received
(62 days to decision)
Review panel
Unknown
Applicant
Diatech, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No