510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861362Substantially Equivalent

Immunomedics Serum Elisa Test System

Immunomedics, Inc., Newark NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861362 is the FDA 510(k) clearance record for IMMUNOMEDICS SERUM ELISA TEST SYSTEM, a class II device, cleared for Immunomedics, Inc. on under FDA product code CZW (Complement C3, Antigen, Antiserum, Control). FDA records list 4 510(k) clearances for Immunomedics, Inc., from to . As of , FDA records show no recalls naming K861362.

Clearance record

Decision date
Received
(57 days to decision)
Product code
CZW Complement C3, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
Device class
Class II
Review panel
Immunology
Applicant
Immunomedics, Inc. 5 Bruce St., Bldg. #5, Newark NJ
Third party review
No

Clearances, product code CZW

Trailing 12 months

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

FDA records show no clearances under product code CZW in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code CZW, 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