510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
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K851319Substantially Equivalent

Dialysis Concentrate

Ries Biologicals, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K851319 is the FDA 510(k) clearance record for DIALYSIS CONCENTRATE, cleared for Ries Biologicals on . FDA records list 2 510(k) clearances for Ries Biologicals, from to . As of , FDA records show no recalls naming K851319.

Clearance record

Decision date
Received
(91 days to decision)
Review panel
Unknown
Applicant
Ries Biologicals 17762 Mitchell St., Irvine CA
Third party review
No