510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K882674Substantially Equivalent

Immu-Mark(tm) Chlamydia Igg/iga Kit

Icn Immunobiologicals, Lisle IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K882674 is the FDA 510(k) clearance record for IMMU-MARK(TM) CHLAMYDIA IGG/IGA KIT, a class I device, cleared for Icn Immunobiologicals on under FDA product code LKH (Antisera, Immunoperoxidase, Chlamydia Spp.). FDA records list 2 510(k) clearances for Icn Immunobiologicals, from to . As of , FDA records show no recalls naming K882674.

Clearance record

Decision date
Received
(413 days to decision)
Product code
LKH Antisera, Immunoperoxidase, Chlamydia Spp.
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Icn Immunobiologicals P.O. Box 1200, Lisle IL
Third party review
No

Clearances, product code LKH

Trailing 12 months

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

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