510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K831496Substantially Equivalent

Allergen Immunosorbents Ip Specific E

Diagnostic Reagent Tech., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K831496 is the FDA 510(k) clearance record for ALLERGEN IMMUNOSORBENTS IP SPECIFIC E, cleared for Diagnostic Reagent Tech. on . FDA records list 10 510(k) clearances for Diagnostic Reagent Tech., from to . As of , FDA records show no recalls naming K831496.

Clearance record

Decision date
Received
(90 days to decision)
Review panel
Unknown
Applicant
Diagnostic Reagent Tech. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No