510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K951851Substantially Equivalent

Alliance Cytomegalovirus Immediate Early Antigen Direct Immunofluorescence Assay

E.I. Dupont de Nemours & Co., Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K951851 is the FDA 510(k) clearance record for ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAY, a class II device, cleared for E.I. Dupont DE Nemours & Co., Inc. on under FDA product code LJO (Antigen, Iha, Cytomegalovirus). FDA records list 253 510(k) clearances for E.I. Dupont DE Nemours & Co., Inc., from to . As of , FDA records show no recalls naming K951851.

Clearance record

Decision date
Received
(460 days to decision)
Product code
LJO Antigen, Iha, Cytomegalovirus
Regulation
21 CFR 866.3175
Device class
Class II
Review panel
Microbiology
Applicant
E.I. Dupont DE Nemours & Co., Inc. Bldg. 500 Mail Box 514, Newark DE
510(k) summary
Statement
Third party review
No

Clearances, product code LJO

Trailing 12 months

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

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