510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K842709Substantially Equivalent

Immustaph Latex Agglutination Kit

Immucell Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842709 is the FDA 510(k) clearance record for IMMUSTAPH LATEX AGGLUTINATION KIT, a class I device, cleared for Immucell Corp. on under FDA product code LHJ (Staphylococcus Aureus Protein A Insoluble). FDA records list one 510(k) clearance for Immucell Corp. As of , FDA records show no recalls naming K842709.

Clearance record

Decision date
Received
(22 days to decision)
Product code
LHJ Staphylococcus Aureus Protein A Insoluble
Regulation
21 CFR 866.3700
Device class
Class I
Review panel
Microbiology
Applicant
Immucell Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LHJ

Trailing 12 months

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

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