510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K821815Substantially Equivalent

Advance C-Reactive Protein (Crp) Assay

Syva Co., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821815 is the FDA 510(k) clearance record for ADVANCE C-REACTIVE PROTEIN (CRP) ASSAY, cleared for Syva Co. on . FDA records list 212 510(k) clearances for Syva Co., from to . As of , FDA records show no recalls naming K821815.

Clearance record

Decision date
Received
(7 days to decision)
Review panel
Unknown
Applicant
Syva Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No