510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K252336Substantially Equivalent

Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay

Diazyme Laboratories, Inc., Poway CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K252336 is the FDA 510(k) clearance record for Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M Assay, cleared for Diazyme Laboratories, Inc. on . FDA records list 52 510(k) clearances for Diazyme Laboratories, Inc., from to . As of , FDA records show no recalls naming K252336.

Clearance record

Decision date
Received
(270 days to decision)
Review panel
Unknown
Applicant
Diazyme Laboratories, Inc. 12889 Gregg Ct., Poway CA
510(k) summary
Statement
Third party review
No