510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K994356Substantially Equivalent

Immunocyt

Diagnocure, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K994356 is the FDA 510(k) clearance record for IMMUNOCYT, a class II device, cleared for Diagnocure, Inc. on under FDA product code NBK (System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer). FDA records list one 510(k) clearance for Diagnocure, Inc. As of , FDA records show no recalls naming K994356.

Clearance record

Decision date
Received
(62 days to decision)
Product code
NBK System, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer
Regulation
21 CFR 864.1860
Device class
Class II
Review panel
Hematology
Applicant
Diagnocure, Inc. 815 Connecticut Ave., NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code NBK

Trailing 12 months

FDA records hold no clearances under product code NBK in the trailing twelve months.

FDA records show no clearances under product code NBK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NBK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260